The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter.
| Device ID | K102589 |
| 510k Number | K102589 |
| Device Name: | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER |
| 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 | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780515630 | K102589 | 000 |
| 10381780515623 | K102589 | 000 |
| 10381780515616 | K102589 | 000 |
| 10381780515593 | K102589 | 000 |
| 10886704041337 | K102589 | 000 |
| 10886704041320 | K102589 | 000 |
| 10886704041313 | K102589 | 000 |
| 10886704040972 | K102589 | 000 |