510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864002Substantially Equivalent

Model 431-06 Polyflex Implantable Pacing Lead

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

K864002 is the FDA 510(k) clearance record for MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD, a class III device, cleared for Intermedics, Inc. on under FDA product code DTB (Permanent Pacemaker Electrode). FDA records list 211 510(k) clearances for Intermedics, Inc., from to . As of , FDA records show no recalls naming K864002.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DTB Permanent Pacemaker Electrode
Regulation
21 CFR 870.3680
Device class
Class III
Review panel
Cardiovascular
Applicant
Intermedics, Inc. P.O. Box 617, Freeport TX
Third party review
No

Clearances, product code DTB

Trailing 12 months

FDA records hold no clearances under product code DTB in the trailing twelve months.

FDA records show no clearances under product code DTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260