INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER— 510(k) K864895

Name: FDA 510(k) clearance K864895
Creator: U.S. Food and Drug Administration
Published: 1987-02-19

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K864895 for INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER, Substantially Equivalent on 1987-02-19. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1986-12-15
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTN

view all

K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
K241206 — Quantum Perfusion Hybrid System2024-07-18
K241053 — MVR Venous Reservoir Bag 800 mL +3 more2024-05-15
K223361 — BMR 1900 PHISIO2023-06-10
K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

More clearances from Johnson & Johnson Professionals, Inc.

view all

K992173 — SIPHONGUARD CSF CONTROL DEVICE2000-04-07
K991413 — CODMAN ETHISORB DURA PATCH2000-03-13
K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT1999-07-09
K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER1998-12-18
K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)1998-12-04

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.