FDA.report

510(k) K240246

Device
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Applicant
Synaptic Medical Corporation
510(k) number
K240246
Product code
DRC
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-26
Date received
2024-01-30
Regulation
870.1390
Classification name
Trocar
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jake Harandi
Address
1959 Kellogg Ave. Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLESynaptic Medical Limited2014-08-29
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K122832MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2012-12-19
K111644MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2011-10-03
K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2008-11-14
K072278BRK TRANSSEPTAL NEEDLESt Jude Medical2007-09-13