510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895972Substantially Equivalent

Curity(r) Percutaneous Catheters

Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895972 is the FDA 510(k) clearance record for CURITY(R) PERCUTANEOUS CATHETERS, a class II device, cleared for Kendall Healthcare Products Co. Div.Of Tyco Health on under FDA product code DQY (Catheter, Percutaneous). FDA records list 66 510(k) clearances for Kendall Healthcare Products Co. Div.Of Tyco Health, from to . As of , FDA records show no recalls naming K895972.

Clearance record

Decision date
Received
(152 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health 15 Hampshire St., Mansfield MA
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260
November 20260