The following data is part of a premarket notification filed by Angiotech with the FDA for Quill Quadrahelix Tissue-closure Device.
| Device ID | K113800 |
| 510k Number | K113800 |
| Device Name: | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell 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 | 2011-12-23 |
| Decision Date | 2012-01-20 |
| Summary: | summary |