The following data is part of a premarket notification filed by Av Medical Technologies Ltd with the FDA for Chameleon Pta Balloon Catheter.
| Device ID | K170635 |
| 510k Number | K170635 |
| Device Name: | Chameleon PTA Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | AV Medical Technologies Ltd 21 B Habarzel Street Tel-aviv, IL 6971029 |
| Contact | Limor Sandach |
| Correspondent | Eliza Malo Dohmen Life Sciences Services, LLC 11925 W I-70 Frontage Rd. North Suite 900 Wheat Ridge, CO 80033 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-02 |
| Decision Date | 2017-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521812314 | K170635 | 000 |
| 10884521812307 | K170635 | 000 |