The following data is part of a premarket notification filed by Hotspur Technologies, Inc., with the FDA for 0.018 Arrow Gpscath Balloon Dilatation Catheter (150 Cm).
| Device ID | K143093 |
| 510k Number | K143093 |
| Device Name: | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 Cm) |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | HOTSPUR TECHNOLOGIES, INC., 880 MAUDE AVENUE, SUITE A Mountain View, CA 94043 |
| Contact | Eric Ankerud, Jd |
| Correspondent | Eric Ankerud, Jd HOTSPUR TECHNOLOGIES, INC., 880 MAUDE AVENUE, SUITE A Mountain View, CA 94043 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-28 |
| Decision Date | 2015-06-24 |
| Summary: | summary |