Product code DTN— Cardiovascular
CARDIOTOMY RESERVOIR
- Classification name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Total cleared
- 169
- First cleared
- Most recent
Market context for product code DTN
FDA has cleared devices under product code DTN between 1976 and 2025, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2017
- 2015
- 2014
- 2013
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
Top applicants under product code DTN
Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DTN
1–100 of 169- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K241206 — Quantum Perfusion Hybrid System
- K241053 — MVR Venous Reservoir Bag 800 mL +3 more
- K223361 — BMR 1900 PHISIO
- K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
- K153143 — Capiox Advance Hardshell Reservoir
- K151110 — Intersept Filtered Cardiotomy Reservoir
- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
- K140321 — INITARY BETTER BLADDER-PEDIATRIC
- K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
- K132972 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
- K131103 — XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
- K122914 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
- K112771 — BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
- K102919 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
- K100507 — XRES BLOOD COLLECTION RESERVOIR
- K090534 — VENOUS HARDSHELL CARDIOTOMY RESERVIORS
- K090690 — VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
- K092315 — SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
- K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
- K083131 — MEDOS HILITE RESERVOIR, MODEL: 4030
- K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
- K082082 — GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
- K070605 — JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
- K072697 — 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
- K070839 — MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
- K061743 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000; VACUUM TIGHT, MODEL BSQ-VHK 2001
- K061527 — CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
- K051606 — GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
- K050195 — V-BAG WITH GBS COATING
- K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
- K040023 — CAPIOX FLEXIBLE VENOUS RESERVOIR
- K033800 — CAPIOX CARDIOTOMY RESERVOIR
- K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
- K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
- K031700 — MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
- K031150 — HEMOBAG, MODEL HBBSD2000
- K030726 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
- K024065 — SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
- K030449 — MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
- K022281 — SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
- K021287 — TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
- K013526 — CAPIOX RX HARDSHELL RESERVOIR
- K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
- K003551 — VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
- K011864 — TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
- K002496 — MODEL 4815 ADAPTER
- K002238 — CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
- K001822 — THE V-BAG
- K001602 — DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
- K994389 — COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
- K993001 — COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
- K992599 — DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
- K991973 — CAPIOX SX10 HARDSHELL RESEVOIR
- K984586 — FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
- K990239 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K982136 — JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
- K984456 — COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K982223 — CAPIOX SX HARDSHELL RESEVOIR
- K980786 — COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
- K981284 — BETTER-BLADDER (BB)
- K981628 — BARD QUANTUM SVR MODEL NUMBER H-6440VR
- K980935 — CAPIOX SX HARDSHELL RESERVOIR
- K974155 — BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
- K971013 — CHASE TEMPERATURE PROBE
- K972017 — BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
- K964908 — VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
- K964907 — VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
- K971669 — COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
- K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
- K964973 — GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
- K961836 — MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
- K953821 — BIOCOR 200 HARDSHELL VENOUS RESERVIOR
- K955046 — SOFT VENOUS RESERVOIR
- K945065 — DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
- K941215 — VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
- K936003 — AFFINITY CVR
- K935717 — AFFINITY VENOUS RESERVIOR BAG
- K934763 — SORIN BLOOD CARDIOPLEGIA SYSTEM
- K934847 — NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
- K936183 — SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
- K933713 — VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
- K936286 — ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
- K933481 — SORIN MONOLYTH VENOUS RESERVOIR
- K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR
- K930299 — BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
- K920178 — CARDIOTOMY RESERVOIR W/20 MICRON FILITER
- K925046 — PLEUR-EVAC CARDIOTOMY RESERVOIR
- K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
- K915573 — VENOUS RESERVOIR W/CARDIOTOMY FILTER
- K920774 — MVR COLLAPSIBLE VENOUS RESERVOIR BAG
- K920312 — NEW COBE CARDIOPLEGIA SYSTEM
- K915737 — AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
- K913915 — BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
- K913956 — BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
- K913692 — VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
- K911790 — MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
- K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
Data sourced from openFDA. This site is unofficial and independent of the FDA.