The following data is part of a premarket notification filed by Vascular Pathways, Inc. with the FDA for Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge.
| Device ID | K112347 |
| 510k Number | K112347 |
| Device Name: | RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VASCULAR PATHWAYS, INC. 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel VASCULAR PATHWAYS, INC. 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-15 |
| Decision Date | 2011-09-22 |
| Summary: | summary |