The following data is part of a premarket notification filed by Creagh Medical Ltd with the FDA for Elm Pta Ballon Dilatation Catheter.
| Device ID | K113468 |
| 510k Number | K113468 |
| Device Name: | ELM PTA BALLON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CREAGH MEDICAL LTD 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell CREAGH MEDICAL LTD 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391525783314 | K113468 | 000 |
| 05391525781518 | K113468 | 000 |
| 05391525781501 | K113468 | 000 |
| 05391525781495 | K113468 | 000 |
| 05391525781488 | K113468 | 000 |
| 05391525781471 | K113468 | 000 |
| 05391525781464 | K113468 | 000 |
| 05391525781457 | K113468 | 000 |
| 05391525781440 | K113468 | 000 |
| 05391525781433 | K113468 | 000 |
| 05391525781426 | K113468 | 000 |
| 05391525781419 | K113468 | 000 |
| 05391525781358 | K113468 | 000 |
| 05391525781310 | K113468 | 000 |
| 05391525781525 | K113468 | 000 |
| 05391525781532 | K113468 | 000 |
| 05391525783307 | K113468 | 000 |
| 05391525783291 | K113468 | 000 |
| 05391525783260 | K113468 | 000 |
| 05391525783253 | K113468 | 000 |
| 05391525783246 | K113468 | 000 |
| 05391525781617 | K113468 | 000 |
| 05391525781600 | K113468 | 000 |
| 05391525781594 | K113468 | 000 |
| 05391525781587 | K113468 | 000 |
| 05391525781570 | K113468 | 000 |
| 05391525781563 | K113468 | 000 |
| 05391525781556 | K113468 | 000 |
| 05391525781549 | K113468 | 000 |
| 05391525781273 | K113468 | 000 |