The following data is part of a premarket notification filed by Sorin Group Usa Inc. with the FDA for Sorin Vasculoop Two Tie Endoscopic Ligation System Model Dtts2.
| Device ID | K122735 |
| 510k Number | K122735 |
| Device Name: | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SORIN GROUP USA INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP USA INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-06 |
| Decision Date | 2013-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622130844 | K122735 | 000 |