The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Intraclude Intra-aortic Catheter.
| Device ID | K132175 |
| 510k Number | K132175 |
| Device Name: | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER |
| Classification | Clamp, Vascular |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Luke Meidell |
| Correspondent | Luke Meidell EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103190007 | K132175 | 000 |