The following data is part of a premarket notification filed by Angioslide, Ltd. with the FDA for Proteus Pta Balloon Catheter With Embolic Capture Feature.
| Device ID | K172494 |
| 510k Number | K172494 |
| Device Name: | PROTEUS PTA Balloon Catheter With Embolic Capture Feature |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Angioslide, Ltd. 4 Ha'Omanut Street, Poleg Industrial Area Netanya, IL 4250438 |
| Contact | Eran Vickus |
| Correspondent | Ilya Burovoy Ilya Burovoy- Regulatory And Quality Consulting 21 Montefiore St. #17 Kiryat Ono, IL 5522635 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290014582033 | K172494 | 000 |
| 07290014582026 | K172494 | 000 |