The following data is part of a premarket notification filed by Angioslide, Ltd with the FDA for Extra Pta Balloon Catheter With Embolic Capture Feature; Proteus Pta Balloon Catheter With Embolic Capture Feature.
| Device ID | K111750 |
| 510k Number | K111750 |
| Device Name: | EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
| Classification | Catheter, Percutaneous |
| Applicant | ANGIOSLIDE, LTD 11925 WEST I-70 FRONTAGE RD NORTH SUITE 900 Clay Anselmo, CO 80033 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo ANGIOSLIDE, LTD 11925 WEST I-70 FRONTAGE RD NORTH SUITE 900 Clay Anselmo, CO 80033 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2011-07-21 |
| Summary: | summary |