The following data is part of a premarket notification filed by Saphena Medical, Inc. with the FDA for Onepass Endoscopic Vessel Harvesting Sysyetm.
| Device ID | K140603 |
| 510k Number | K140603 |
| Device Name: | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SAPHENA MEDICAL, INC. 27392 CAPRICHO Mission Viejo, CA 92692 |
| Contact | Cheryl Blake |
| Correspondent | Cheryl Blake SAPHENA MEDICAL, INC. 27392 CAPRICHO Mission Viejo, CA 92692 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M718VPX4000 | K140603 | 000 |
| 00888233078986 | K140603 | 000 |