The following data is part of a premarket notification filed by Surgical Specialties Corp. Dba Angiotech with the FDA for Tranquill Barbed Device.
| Device ID | K133420 |
| 510k Number | K133420 |
| Device Name: | TRANQUILL BARBED DEVICE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-08 |
| Decision Date | 2013-11-29 |
| Summary: | summary |