The following data is part of a premarket notification filed by Angioslide, Ltd with the FDA for Extra Pta Balloon Catheter With Embolic Protection Feature.
| Device ID | K090364 |
| 510k Number | K090364 |
| Device Name: | EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ANGIOSLIDE, LTD 18905 CELEBRITY LANE Sandy Spring, MD 20860 |
| Contact | Elisa Harvey |
| Correspondent | Elisa Harvey ANGIOSLIDE, LTD 18905 CELEBRITY LANE Sandy Spring, MD 20860 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-13 |
| Decision Date | 2010-03-23 |
| Summary: | summary |