The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Lasso Nav Eco And Lasso 2515 Nav Eco Variable Electrophysiology (ep) Catheter.
| Device ID | K153006 |
| 510k Number | K153006 |
| Device Name: | Reprocessed Lasso NAV Eco And Lasso 2515 NAV Eco Variable Electrophysiology (EP) Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | STERILMED, INC. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| Contact | Patricia F Kaufman |
| 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 | 2015-10-14 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551045070 | K153006 | 000 |
| 10888551044813 | K153006 | 000 |
| 10888551044806 | K153006 | 000 |
| 10888551044790 | K153006 | 000 |
| 10888551006705 | K153006 | 000 |
| 10888551006699 | K153006 | 000 |
| 10888551006682 | K153006 | 000 |
| 10888551006675 | K153006 | 000 |
| 10888551006668 | K153006 | 000 |
| 10888551006651 | K153006 | 000 |
| 10888551006644 | K153006 | 000 |
| 10888551006637 | K153006 | 000 |
| 10888551006620 | K153006 | 000 |
| 10888551044820 | K153006 | 000 |
| 10888551044837 | K153006 | 000 |
| 10888551045063 | K153006 | 000 |
| 10888551045056 | K153006 | 000 |
| 10888551045049 | K153006 | 000 |
| 10888551045032 | K153006 | 000 |
| 10888551045018 | K153006 | 000 |
| 10888551045001 | K153006 | 000 |
| 10888551044998 | K153006 | 000 |
| 10888551044981 | K153006 | 000 |
| 10888551044875 | K153006 | 000 |
| 10888551044868 | K153006 | 000 |
| 10888551044851 | K153006 | 000 |
| 10888551044844 | K153006 | 000 |
| 10888551006613 | K153006 | 000 |