The following data is part of a premarket notification filed by Wildcat Medical Inc with the FDA for Tripleplay-vt Vascular Therapy System.
Device ID | K103187 |
510k Number | K103187 |
Device Name: | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM |
Classification | Sleeve, Limb, Compressible |
Applicant | WILDCAT MEDICAL INC 284 RIDGE ROAD Hinckley, OH 44233 |
Contact | Joe Adkins |
Correspondent | Joe Adkins WILDCAT MEDICAL INC 284 RIDGE ROAD Hinckley, OH 44233 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-28 |
Decision Date | 2011-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042809585940 | K103187 | 000 |
04042809585933 | K103187 | 000 |
04042809585919 | K103187 | 000 |
04042809585902 | K103187 | 000 |
04042809585858 | K103187 | 000 |
04042809585841 | K103187 | 000 |
04042809585735 | K103187 | 000 |
04042809585728 | K103187 | 000 |