The following data is part of a premarket notification filed by Hotspur Technologies with the FDA for Gpscath Ballon Dilatation Catheter.
| Device ID | K113769 |
| 510k Number | K113769 |
| Device Name: | GPSCATH BALLON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-01-20 |
| Summary: | summary |