510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813518Substantially Equivalent

Implant Aid Splicing Crimp & Sleeve

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

K813518 is the FDA 510(k) clearance record for IMPLANT AID SPLICING CRIMP & SLEEVE, a class III device, cleared for Intermedics, Inc. on under FDA product code KFJ (Materials, Repair Or Replacement, Pacemaker). FDA records list 211 510(k) clearances for Intermedics, Inc., from to . As of , FDA records show no recalls naming K813518.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KFJ Materials, Repair Or Replacement, Pacemaker
Regulation
21 CFR 870.3710
Device class
Class III
Review panel
Cardiovascular
Applicant
Intermedics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KFJ

Trailing 12 months

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

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