The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Bactiseal Catheters.
Device ID | K003322 |
510k Number | K003322 |
Device Name: | CODMAN BACTISEAL CATHETERS |
Classification | Catheter, Ventricular |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | James M Flaherty |
Correspondent | James M Flaherty Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | HCA |
CFR Regulation Number | 882.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-24 |
Decision Date | 2001-10-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780526803 | K003322 | 000 |
10886704048510 | K003322 | 000 |
10886704048497 | K003322 | 000 |
10886704048480 | K003322 | 000 |
10886704046974 | K003322 | 000 |
10886704046967 | K003322 | 000 |