The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Electrophysiology Catheters.
| Device ID | K082023 |
| 510k Number | K082023 |
| Device Name: | REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
| 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 | 2008-07-16 |
| Decision Date | 2008-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825001384 | K082023 | 000 |
| 00885825001377 | K082023 | 000 |
| 00885825001360 | K082023 | 000 |
| 00885825001353 | K082023 | 000 |
| 00885825001346 | K082023 | 000 |
| 00885825001339 | K082023 | 000 |
| 00885825001322 | K082023 | 000 |