The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Vari-pass Variable Length Access Sheath.
| Device ID | K123170 |
| 510k Number | K123170 |
| Device Name: | VARI-PASS VARIABLE LENGTH ACCESS SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925027589 | K123170 | 000 |