510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K924388Substantially Equivalent

Angemed Model 4000 Qc Bipolar Temp Pacing Lead

Angemed, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924388 is the FDA 510(k) clearance record for ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD, a class II device, cleared for Angemed, Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 2 510(k) clearances for Angemed, Inc., from to . As of , FDA records show no recalls naming K924388.

Clearance record

Decision date
Received
(416 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Angemed, Inc. 3650 Annapolis Ln., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code LDF

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