Atlas FDA

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k) clearance K122832 · decided 2012-12-19

Clearance details

K-number
K122832
Device name
MOBICATH TRANSSEPTAL NEEDLE
Applicant
Great Batch Medical
Decision
Substantially Equivalent
Date received
2012-09-17
Decision date
2012-12-19
Days to decision
93 days
Clearance type
Special
Product code
DRC
Device class
2
Regulation number
870.1390
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246)Synaptic Medical Corporation2024-07-26
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042)Pressure Products Medical Device Manufacturing, LLC2024-05-17
SafeSept® Transseptal Guidewire (SS-140) (K221707)Pressure Products Medical Device Manufacturing, LLC2022-09-14
PathBuilder Transseptal Needle (K212625)Shanghai Microport EP Medtech Co., Ltd.2022-03-23
SafeSept Blunt Needle (K210328)Pressure Products Medical Device Manufacturing, LLC2021-03-05
TSN Transseptal Needle (K172950)Pressure Products Medical Device Manufacturing, LLC2018-02-21
Needle Free Transseptal Cannula (K172934)Pressure Products Medical Device Manufacturing, LLC2018-02-16
SafeSept Needle Free Transseptal Guidewire (K172893)Pressure Products Medical Device Manufacturing, LLC2017-12-21
SafeSept Transseptal Guidewire (K170671)Pressure Products Medical Device Manufacturing, LLC2017-10-20
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (K132943)Synaptic Medical Limited2014-08-29
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (K130843)Oscor, Inc.2014-01-08
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587)St Jude Medical2013-02-07

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Myopore® Sutureless Myocardial Pacing Lead (P130012/S016)Great Batch Medical2024-04-19
Myopore Sutureless Myocardial Pacing Lead (P130012/S015)Great Batch Medical2023-12-13
Myopore® Sutureless Myocardial Pacing Lead (P130012/S014)Great Batch Medical2023-07-07
Myopore® Sutureless Myocardial Pacing Lead (P130012/S013)Great Batch Medical2023-02-07
Myopore Sutureless Myocardial Pacing Lead (P130012/S010)Great Batch Medical2022-12-12
Myopore® Sutureless Myocardial Pacing Lead (P130012/S009)Great Batch Medical2022-10-05
Myopore Sutureless Myocardial Pacing Lead (P130012/S007)Great Batch Medical2019-07-15
Myopore Sutureless Myocardial Pacing Lead (P130012/S008)Great Batch Medical2019-07-03