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 | K120164 |
| 510k Number | K120164 |
| Device Name: | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ANGIOSLIDE, LTD 11925 W. I-70 FRONTAGE RD NORTH, STE 900 Wheat Ridge, CO 80033 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo ANGIOSLIDE, LTD 11925 W. I-70 FRONTAGE RD NORTH, STE 900 Wheat Ridge, CO 80033 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-06-08 |
| Summary: | summary |