510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K990142Substantially Equivalent - Subject to Tracking Reg.

Ht, Model Ht Pb

Sulzer Oscor, Inc., Palm Harbor FL / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K990142 is the FDA 510(k) clearance record for HT, MODEL HT PB, a class III device, cleared for Sulzer Oscor, Inc. on under FDA product code DTB (Permanent Pacemaker Electrode). FDA records list 2 510(k) clearances for Sulzer Oscor, Inc., from to . As of , FDA records show no recalls naming K990142.

Clearance record

Decision date
Received
(192 days to decision)
Product code
DTB Permanent Pacemaker Electrode
Regulation
21 CFR 870.3680
Device class
Class III
Review panel
Cardiovascular
Applicant
Sulzer Oscor, Inc. 3816 Desoto Blvd., Palm Harbor FL
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