The following data is part of a premarket notification filed by Angiotech with the FDA for Quill Polypropylene Knotless Tissue-closure Device, Variable Loop Design.
| Device ID | K151112 |
| 510k Number | K151112 |
| Device Name: | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Contact | Hilary Wells |
| Correspondent | Hilary Wells ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-28 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782000491 | K151112 | 000 |
| 10848782000484 | K151112 | 000 |
| 10848782000477 | K151112 | 000 |
| 10848782040190 | K151112 | 000 |
| 10848782040183 | K151112 | 000 |
| 10848782040176 | K151112 | 000 |
| 10848782040169 | K151112 | 000 |
| 10848782037145 | K151112 | 000 |
| 10848782024671 | K151112 | 000 |