The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Electrophysiology Diagnostic Catheters.
| Device ID | K150357 |
| 510k Number | K150357 |
| Device Name: | Reprocessed Electrophysiology Diagnostic Catheters |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | STERILMED, INC. 5010 Cheshire Pkwy Ste 2 Plymouth, MN 55446 |
| Contact | Nicole Boser |
| Correspondent | Patricia F Kaufman STERILMED, INC. 5010 Cheshire Parkway Suite 2 Plymouth, MN 55446 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551039505 | K150357 | 000 |
| 10888551039499 | K150357 | 000 |