The following data is part of a premarket notification filed by Cardio Thoracic Systems with the FDA for Acier Sutures.
| Device ID | K991073 |
| 510k Number | K991073 |
| Device Name: | ACIER SUTURES |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIO THORACIC SYSTEMS 10600 N. TANTAU AVE. Cupertino, CA 95014 -0739 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13661522014810 | K991073 | 000 |
| 13661522005696 | K991073 | 000 |
| 13661522005702 | K991073 | 000 |
| 13661522005719 | K991073 | 000 |
| 13661522005726 | K991073 | 000 |
| 13661522005733 | K991073 | 000 |
| 13661522005740 | K991073 | 000 |
| 13661522005757 | K991073 | 000 |
| 13661522005764 | K991073 | 000 |
| 13661522043582 | K991073 | 000 |
| 13661522040789 | K991073 | 000 |
| 13661522033446 | K991073 | 000 |
| 13661522024093 | K991073 | 000 |
| 13661522024109 | K991073 | 000 |
| 13661522024116 | K991073 | 000 |
| 13661522024123 | K991073 | 000 |
| 13661522025243 | K991073 | 000 |
| 13661522028664 | K991073 | 000 |
| 13661522030926 | K991073 | 000 |
| 13661522033392 | K991073 | 000 |
| 13661522005849 | K991073 | 000 |
| 13661522005863 | K991073 | 000 |
| 13661522005870 | K991073 | 000 |
| 13661522011055 | K991073 | 000 |
| 13661522011390 | K991073 | 000 |
| 13661522011406 | K991073 | 000 |
| 13661522011413 | K991073 | 000 |
| 13661522011451 | K991073 | 000 |
| 13661522012205 | K991073 | 000 |
| 13661522028138 | K991073 | 000 |
| 13661522032586 | K991073 | 000 |
| 13661522009595 | K991073 | 000 |
| 13661522009472 | K991073 | 000 |
| 13661522009366 | K991073 | 000 |
| 13661522007614 | K991073 | 000 |
| 13661522007621 | K991073 | 000 |
| 13661522008734 | K991073 | 000 |
| 13661522008741 | K991073 | 000 |
| 13661522008789 | K991073 | 000 |
| 13661522008796 | K991073 | 000 |
| 13661522009175 | K991073 | 000 |
| 13661522009182 | K991073 | 000 |
| 13661522038885 | K991073 | 000 |