510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K963716Substantially Equivalent

Mics Device System

Percutaneous Technologies, Walnut CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963716 is the FDA 510(k) clearance record for MICS DEVICE SYSTEM, a class II device, cleared for Percutaneous Technologies, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 3 510(k) clearances for Percutaneous Technologies, Inc., from to . As of , FDA records show no recalls naming K963716.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Percutaneous Technologies, Inc. 773 Trotter Ct., Walnut CA
510(k) summary
Statement
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260