The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Percutaneous Sheath Introducer.
| Device ID | K121185 |
| 510k Number | K121185 |
| Device Name: | EDWARDS PERCUTANEOUS SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | Spencer Walker |
| Correspondent | Spencer Walker EDWARDS LIFESCIENCES, LLC. 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2012-08-22 |
| Summary: | summary |