510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853410Substantially Equivalent

Model 492-03 Polyflex Implantable Pacing Lead

Intermedics, Inc., Freeport TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853410 is the FDA 510(k) clearance record for MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD, a class II device, cleared for Intermedics, Inc. on under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). FDA records list 211 510(k) clearances for Intermedics, Inc., from to . As of , FDA records show no recalls naming K853410.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DTR Heat-Exchanger, Cardiopulmonary Bypass
Regulation
21 CFR 870.4240
Device class
Class II
Review panel
Cardiovascular
Applicant
Intermedics, Inc. P.O. Box 617, Freeport TX
Third party review
No

Clearances, product code DTR

Trailing 12 months
1 clearance under product code DTR 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 DTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260