Data / Medical devices / United States / Synaptic Medical Corporation

Synaptic Medical Corporation: FDA-registered device maker in Carlsbad, CA, United States, 7 510(k) clearances

Name: Synaptic Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Synaptic Medical Corporation is registered with the FDA (registration 3013400708) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 6, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Synaptic Medical Corporation

FDA registration number: 3013400708
Address: 1959 Kellogg Ave, Carlsbad, CA, United States, 92008
Owner or operator: Synaptic Medical Corp (10054312)
Roles: Complaint file establishment, Manufacturer
First device listed: March 7, 2017
Registered through: 2027
Brand names listed: Accusafe Transseptal Guidewire, Electrophysiology Catheter, Intracardiac Catheter Introducer Kit and Transseptal Needle, Navigo 12F Steerable Intracardiac Catheter Introducer Kit, Nordica PV Cryo Mapping Catheter, RithmID-SD Steerable Diagnostic Electrophysiology Catheter, Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Guidewire, Catheter, Reprocessed	NKQ	2	Complaint file establishment	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Trocar	DRC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 6, 2024	K233900	Nordica PV Cryo Mapping Catheter	DRF	Substantially Equivalent	Synaptic Medical Corporation	accessdata.fda.gov
July 26, 2024	K240246	Accusafe Transseptal Guidewire (GTR31180, GTR31230)	DRC	Substantially Equivalent	Synaptic Medical Corporation	accessdata.fda.gov
February 16, 2024	K233708	NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)	DYB	Substantially Equivalent	Synaptic Medical Corporation	accessdata.fda.gov
February 14, 2022	K203793	RithmID-SD Steerable Diagnostic Electrophysiology Catheter	DRF	Substantially Equivalent	Synaptic Medical Corporation	accessdata.fda.gov
December 4, 2015	K151936	Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle	DYB	Unknown	Synaptic Medical Limited	accessdata.fda.gov
August 29, 2014	K132943	INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE	DRC	Substantially Equivalent	Synaptic Medical Limited	accessdata.fda.gov
March 4, 2014	K133028	RITHM ID ELECTROPHYSIOLOGY CATHETER	DRF	Substantially Equivalent	Synaptic Medical Limited	accessdata.fda.gov

Compare with other makers

Updated September 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.