510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800353Substantially Equivalent

Adapter Kit

Daig Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800353 is the FDA 510(k) clearance record for ADAPTER KIT, a class II device, cleared for Daig Corp. on under FDA product code DTD (Pacemaker Lead Adaptor). FDA records list 27 510(k) clearances for Daig Corp., from to . As of , FDA records show no recalls naming K800353.

Clearance record

Decision date
Received
(103 days to decision)
Product code
DTD Pacemaker Lead Adaptor
Regulation
21 CFR 870.3620
Device class
Class II
Review panel
Cardiovascular
Applicant
Daig Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTD

Trailing 12 months

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

FDA records show no clearances under product code DTD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTD, 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