510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K130714Substantially Equivalent

Progigy Support Catheter

Radius Medical, LLC, Hudson MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130714 is the FDA 510(k) clearance record for PROGIGY SUPPORT CATHETER, a class II device, cleared for Radius Medical, LLC on under FDA product code DQY (Catheter, Percutaneous). FDA records list one 510(k) clearance for Radius Medical, LLC. As of , FDA records show no recalls naming K130714.

Clearance record

Decision date
Received
(160 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Radius Medical, LLC 577 Main St. Suite 360, Hudson MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260