The following data is part of a premarket notification filed by Hotspur Technologies,inc Subsidiary Of Teleflex Me with the FDA for Arrow Gpscath Balloon Dilatation Catheter.
| Device ID | K140351 |
| 510k Number | K140351 |
| Device Name: | ARROW GPSCATH BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME 880 Maude Ave Ste A Mountain View, CA 94043 |
| Contact | Eric Ankerud, Jd |
| Correspondent | Eric Ankerud, Jd HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME 880 Maude Ave Ste 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 | 2014-02-11 |
| Decision Date | 2014-07-02 |
| Summary: | summary |