510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K071421Substantially Equivalent

Promepla Intravascular Administration Set and Extension Set

Promepla, Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071421 is the FDA 510(k) clearance record for PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET, a class II device, cleared for Promepla on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Promepla. As of , FDA records show no recalls naming K071421.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Promepla 5600 Wisconsin Ave., Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260