The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set.
| Device ID | K090348 |
| 510k Number | K090348 |
| Device Name: | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Sharon Mcdermott |
| Correspondent | Sharon Mcdermott Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-11 |
| Decision Date | 2009-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780525509 | K090348 | 000 |
| 10381780524083 | K090348 | 000 |
| 10381780518457 | K090348 | 000 |
| 10381780518440 | K090348 | 000 |
| 10886704040996 | K090348 | 000 |
| 10886704040989 | K090348 | 000 |
| 10886704047261 | K090348 | 000 |
| 10886704045199 | K090348 | 000 |