The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Bactiseal Barium Striped Catheters.
| Device ID | K031123 |
| 510k Number | K031123 |
| Device Name: | CODMAN BACTISEAL BARIUM STRIPED CATHETERS |
| Classification | Catheter, Ventricular |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Elizabeth Dolan |
| Correspondent | Elizabeth Dolan Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-09 |
| Decision Date | 2003-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780526797 | K031123 | 000 |
| 10381780524076 | K031123 | 000 |
| 10381780524069 | K031123 | 000 |
| 10381780524052 | K031123 | 000 |
| 10886704048503 | K031123 | 000 |
| 10886704045175 | K031123 | 000 |
| 10886704045168 | K031123 | 000 |
| 10886704045151 | K031123 | 000 |