The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Electrophysiology Diagnostic Catheters.
| Device ID | K092158 |
| 510k Number | K092158 |
| Device Name: | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Dennis Toussaint |
| Correspondent | Dennis Toussaint STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-16 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551042321 | K092158 | 000 |
| 10888551034937 | K092158 | 000 |
| 10888551034906 | K092158 | 000 |
| 10888551034890 | K092158 | 000 |