The following data is part of a premarket notification filed by Hotspur Technologies with the FDA for Pta-plus Pta Balloon Cather 5 Mm X 4cm, Pta-plus Pta Balloon Catheter 6mm X 4cm.
| Device ID | K100842 |
| 510k Number | K100842 |
| Device Name: | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM |
| Classification | Catheter, Embolectomy |
| Applicant | HOTSPUR TECHNOLOGIES 880 MAUDE AVENUE SUITE A Mountain View, CA 94043 |
| Contact | Eric Ankerud |
| Correspondent | Eric Ankerud HOTSPUR TECHNOLOGIES 880 MAUDE AVENUE SUITE A Mountain View, CA 94043 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-07-12 |
| Summary: | summary |