510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964604Substantially Equivalent - Subject to Tracking & PMS

Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation

BIOTRONIK AG, Lake Oswego OR / Traditional, Substantially Equivalent - Subject to Tracking & PMS
FDA source (opens on fda.gov)

K964604 is the FDA 510(k) clearance record for BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION, a class III device, cleared for Biotronik, Inc. on under FDA product code DTB (Permanent Pacemaker Electrode). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K964604.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DTB Permanent Pacemaker Electrode
Regulation
21 CFR 870.3680
Device class
Class III
Review panel
Cardiovascular
Applicant
Biotronik, Inc. 6024 Jean Rd., Lake Oswego OR
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260