The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Daig Livewire Electrophysiology Catheters.
| Device ID | K052603 |
| 510k Number | K052603 |
| Device Name: | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS |
| 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 | 2005-09-21 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825005672 | K052603 | 000 |
| 00885825006907 | K052603 | 000 |
| 00885825006914 | K052603 | 000 |
| 00885825006921 | K052603 | 000 |
| 00885825006938 | K052603 | 000 |
| 00885825006945 | K052603 | 000 |
| 00885825006952 | K052603 | 000 |
| 00885825006969 | K052603 | 000 |
| 00885825006976 | K052603 | 000 |
| 00885825006891 | K052603 | 000 |
| 00885825006884 | K052603 | 000 |
| 00885825006808 | K052603 | 000 |
| 00885825006815 | K052603 | 000 |
| 00885825006822 | K052603 | 000 |
| 00885825006839 | K052603 | 000 |
| 00885825006846 | K052603 | 000 |
| 00885825006853 | K052603 | 000 |
| 00885825006860 | K052603 | 000 |
| 00885825006877 | K052603 | 000 |
| 00885825006983 | K052603 | 000 |
| 00885825006990 | K052603 | 000 |
| 00885825007003 | K052603 | 000 |
| 00885825007362 | K052603 | 000 |
| 00885825007379 | K052603 | 000 |
| 00885825007386 | K052603 | 000 |
| 00885825007393 | K052603 | 000 |
| 00885825007409 | K052603 | 000 |
| 00885825007416 | K052603 | 000 |
| 00885825007423 | K052603 | 000 |
| 00885825007683 | K052603 | 000 |
| 00885825007355 | K052603 | 000 |
| 00885825007348 | K052603 | 000 |
| 00885825007263 | K052603 | 000 |
| 00885825007270 | K052603 | 000 |
| 00885825007287 | K052603 | 000 |
| 00885825007294 | K052603 | 000 |
| 00885825007300 | K052603 | 000 |
| 00885825007317 | K052603 | 000 |
| 00885825007324 | K052603 | 000 |
| 00885825007331 | K052603 | 000 |
| 00885825007690 | K052603 | 000 |