The following data is part of a premarket notification filed by Hotspur Technologies, Inc., with the FDA for Arrow Gpscath Balloon Dialation Catheter (150 Cm).
| Device ID | K142300 |
| 510k Number | K142300 |
| Device Name: | Arrow GPSCath Balloon Dialation Catheter (150 Cm) |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | HOTSPUR TECHNOLOGIES, INC., A SUBSIDIARY OF TELEFLEX MEDICAL, INC. 880 MAUDE AVENUE, SUITE A Mountain View, CA 94043 |
| Contact | Erick Ankerud |
| Correspondent | Erick Ankerud HOTSPUR TECHNOLOGIES, INC., A SUBSIDIARY OF TELEFLEX MEDICAL, INC. 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 | 2014-08-18 |
| Decision Date | 2014-09-17 |
| Summary: | summary |