The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Cs Bi-diectional Diagnostic Electrophysiology Catheter.
| Device ID | K100254 |
| 510k Number | K100254 |
| Device Name: | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2010-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825000288 | K100254 | 000 |
| 00885825000271 | K100254 | 000 |
| 00885825000264 | K100254 | 000 |
| 00885825000257 | K100254 | 000 |
| 07613327357318 | K100254 | 000 |
| 07613327357301 | K100254 | 000 |