The following data is part of a premarket notification filed by W.l Gore And Associates Inc with the FDA for Gore Molding And Occlusion Balloon Catheter.
| Device ID | K172567 |
| 510k Number | K172567 |
| Device Name: | GORE Molding And Occlusion Balloon Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | W.L Gore And Associates Inc 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Contact | Jeremiah Andrews |
| Correspondent | Jeremiah Andrews W.L Gore And Associates Inc 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-25 |
| Decision Date | 2018-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132639489 | K172567 | 000 |