510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132943Substantially Equivalent

Intracardic Catheter Introducer Kit and Transseptal Needle

Synaptic Medical Corporation, Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132943 is the FDA 510(k) clearance record for INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE, a class II device, cleared for Synaptic Medical Limited on under FDA product code DRC (Trocar). FDA records list 7 510(k) clearances for Synaptic Medical Limited, from to . As of , FDA records show no recalls naming K132943.

Clearance record

Decision date
Received
(344 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
Synaptic Medical Limited P.O. Box 120-119, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRC

Trailing 12 months

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

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