The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Codman Certas Plus Programmable Valve.
| Device ID | K182265 |
| 510k Number | K182265 |
| Device Name: | CodMan Certas Plus Programmable Valve |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Contact | Nancy Macdonald |
| Correspondent | Nancy Macdonald Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-21 |
| Decision Date | 2018-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780529477 | K182265 | 000 |
| 10381780529255 | K182265 | 000 |
| 10381780529279 | K182265 | 000 |
| 10381780529293 | K182265 | 000 |
| 10381780529316 | K182265 | 000 |
| 10381780529330 | K182265 | 000 |
| 10381780529354 | K182265 | 000 |
| 10381780529378 | K182265 | 000 |
| 10381780529392 | K182265 | 000 |
| 10381780529415 | K182265 | 000 |
| 10381780529491 | K182265 | 000 |
| 10381780529514 | K182265 | 000 |
| 10381780529538 | K182265 | 000 |
| 10381780529439 | K182265 | 000 |
| 10381780529453 | K182265 | 000 |
| 10381780529231 | K182265 | 000 |