The following data is part of a premarket notification filed by Angiotech with the FDA for Quill Pdo Knotless Tissue-closure Device (polydioxanone).
| Device ID | K113744 |
| 510k Number | K113744 |
| Device Name: | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-20 |
| Decision Date | 2012-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020826 | K113744 | 000 |
| 20705031227955 | K113744 | 000 |
| 10848782020581 | K113744 | 000 |
| 10848782020604 | K113744 | 000 |
| 10848782020628 | K113744 | 000 |
| 10848782020642 | K113744 | 000 |
| 10848782020666 | K113744 | 000 |
| 10848782020673 | K113744 | 000 |
| 10848782020680 | K113744 | 000 |
| 10848782020697 | K113744 | 000 |
| 10848782020741 | K113744 | 000 |
| 10848782020765 | K113744 | 000 |
| 10848782020772 | K113744 | 000 |
| 20705031227948 | K113744 | 000 |