The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Retroflex 3 Introducer Sheath Set, Models 9120s23 And 9120s26.
| Device ID | K093877 |
| 510k Number | K093877 |
| Device Name: | RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 |
| Classification | Introducer, Catheter |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason K Lyon |
| Correspondent | Jason K Lyon EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-07-01 |
| Summary: | summary |