510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864895Substantially Equivalent

Intersept* Cardiotomy Reservoir with Filter

Johnson & Johnson Professionals, Inc., King Of Prussia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864895 is the FDA 510(k) clearance record for INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K864895.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Johnson & Johnson Professionals, Inc. P.O. Box 386, King Of Prussia PA
Third party review
No

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260