510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860867Substantially Equivalent

Digital Subtraction Angiography Catheters and Sets

Medical Components, Inc., Harleysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860867 is the FDA 510(k) clearance record for DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS, a class II device, cleared for Medical Components, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 72 510(k) clearances for Medical Components, Inc., from to . As of , FDA records show no recalls naming K860867.

Clearance record

Decision date
Received
(117 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Medical Components, Inc. 1499 Delp Dr., Harleysville PA
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260