The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe.
| Device ID | K152633 |
| 510k Number | K152633 |
| Device Name: | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | EDWARDS LIFESCIENCES, LLC ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell EDWARDS LIFESCIENCES, LLC ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2015-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103147421 | K152633 | 000 |
| 00690103147407 | K152633 | 000 |