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 |