The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Electrophysiology Catheter.
| Device ID | K052414 |
| 510k Number | K052414 |
| Device Name: | REPROCESSED ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Elizabeth Renken |
| Correspondent | Elizabeth Renken ALLIANCE MEDICAL CORP. 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 | 2005-09-02 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825008741 | K052414 | 000 |
| 00885825008031 | K052414 | 000 |
| 00885825008024 | K052414 | 000 |
| 00885825008017 | K052414 | 000 |
| 00885825008000 | K052414 | 000 |
| 00885825007997 | K052414 | 000 |
| 00885825007980 | K052414 | 000 |
| 00885825007973 | K052414 | 000 |
| 00885825007966 | K052414 | 000 |
| 00885825007959 | K052414 | 000 |
| 00885825007942 | K052414 | 000 |
| 00885825007935 | K052414 | 000 |
| 00885825007928 | K052414 | 000 |
| 00885825007911 | K052414 | 000 |
| 00885825007904 | K052414 | 000 |
| 00885825008215 | K052414 | 000 |
| 00885825008543 | K052414 | 000 |
| 00885825008734 | K052414 | 000 |
| 00885825008727 | K052414 | 000 |
| 00885825008710 | K052414 | 000 |
| 00885825008703 | K052414 | 000 |
| 00885825008697 | K052414 | 000 |
| 00885825008635 | K052414 | 000 |
| 00885825008628 | K052414 | 000 |
| 00885825008611 | K052414 | 000 |
| 00885825008604 | K052414 | 000 |
| 00885825008598 | K052414 | 000 |
| 00885825008581 | K052414 | 000 |
| 00885825008574 | K052414 | 000 |
| 00885825008567 | K052414 | 000 |
| 00885825008550 | K052414 | 000 |
| 00885825007898 | K052414 | 000 |