The following data is part of a premarket notification filed by Stryker Sustainability Solutions, Inc. with the FDA for Reprocessed Steerable Introducer.
| Device ID | K123334 |
| 510k Number | K123334 |
| Device Name: | REPROCESSED STEERABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS, INC. 10232 S. 51st St. Phoenix, AZ 85044 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock STRYKER SUSTAINABILITY SOLUTIONS, INC. 10232 S. 51st St. Phoenix, AZ 85044 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825011727 | K123334 | 000 |
| 00885825011710 | K123334 | 000 |
| 00885825011703 | K123334 | 000 |