510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003322Substantially Equivalent

Codman Bactiseal Catheters

Cerenovus, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003322 is the FDA 510(k) clearance record for CODMAN BACTISEAL CATHETERS, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code HCA (Catheter, Ventricular). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K003322.

Clearance record

Decision date
Received
(342 days to decision)
Product code
HCA Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Codman & Shurtleff, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary
Third party review
No

Clearances, product code HCA

Trailing 12 months

FDA records hold no clearances under product code HCA in the trailing twelve months.

FDA records show no clearances under product code HCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260