Product code DTZ— Cardiovascular
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
- Classification name
- Oxygenator, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Total cleared
- 254
- First cleared
- Most recent
Clearances under product code DTZ — page 2
101–200 of 254- K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
- K023381 — VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
- K030264 — QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
- K022450 — INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
- K022115 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
- K013038 — SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
- K020997 — APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K020351 — D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
- K014080 — APEX ADULT HOLLOWE FIBER OXYGENATOR
- K013915 — D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
- K010443 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
- K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
- K004001 — MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
- K010478 — DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
- K980974 — SAFE MINI
- K993772 — X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
- K000255 — COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
- K001021 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
- K000430 — AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
- K991737 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
- K990103 — MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
- K991452 — COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
- K992559 — HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
- K992910 — AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
- K984271 — MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
- K974812 — COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
- K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
- K974085 — COBE OXYGENATOR PRODUCTS
- K963518 — COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
- K971877 — LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
- K964043 — COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
- K961734 — CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
- K970463 — CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
- K964967 — BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
- K953976 — SAFE MICRO
- K962641 — MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
- K961530 — GISH RELIANCE OXYGENATOR (MODEL HFO)
- K954850 — BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
- K960074 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
- K962667 — CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
- K961000 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
- K953835 — LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
- K951247 — SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
- K941473 — MAXIMA PLUS HOLLOW FIBER OXYGENATOR
- K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
- K941225 — UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
- K934292 — WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
- K931444 — PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
- K933586 — MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE
- K932252 — AFFINITY HOLLOW FIBER OXYGENATOR
- K926467 — COBE CMS-FS MEMBRANE OXYGENATOR
- K922799 — CAPIOX SX HOLLOW FIBER OXYGENATOR
- K926226 — INTERSEPT FILTERED CARDIOTOMY RESERVOIR
- K925075 — SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
- K925076 — SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
- K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
- K925626 — MAXIMA PLUS HOLLOW FIBER OXYGENATOR
- K922933 — SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
- K920889 — MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
- K912082 — SAFE II
- K912079 — SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
- K912920 — SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
- K912655 — MINIMAX OXYGENATION SYSTEM
- K897068 — MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
- K912078 — SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
- K911227 — NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
- K910107 — DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
- K903436 — SARNS MEMBRANE OXGENATOR PART NUMBER 9443
- K901253 — (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
- K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
- K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
- K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
- K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
- K896978 — CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
- K896671 — SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
- K892664 — CARDIOPULMONARY SUPPORT (CPS) SYSTEM
- K893704 — SAFE-1
- K893207 — CLOSED CHEST SUPPORT CIRCUIT
- K895632 — SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
- K895393 — SARNS INGANT MEMBRANE OXYGENATOR
- K892641 — BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
- K894970 — WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
- K894630 — SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
- K894103 — SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
- K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
- K891230 — MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
- K890808 — SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
- K882892 — MEMBRANE OXYGENATOR
- K883053 — SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
- K883054 — SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
- K880021 — COBE CML3
- K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
- K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
- K872107 — WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
- K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS
- K864235 — BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
- K863476 — SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
- K863515 — MODIFIED SARNS OXYGENATOR SYSTEM
- K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS
- K861641 — HEPARIN-COATED EXTRACORPOREAL CIRCUITS
Data sourced from openFDA. This site is unofficial and independent of the FDA.