Atlas FDA

BRK TRANSSEPTAL NEEDLE

FDA 510(k) clearance K072278 · decided 2007-09-13

Clearance details

K-number
K072278
Device name
BRK TRANSSEPTAL NEEDLE
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2007-08-16
Decision date
2007-09-13
Days to decision
28 days
Clearance type
Traditional
Product code
DRC
Device class
2
Regulation number
870.1390
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minnetonka, MN, US
Third-party review
Yes
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
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S096)St Jude Medical2025-12-23
TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S094)St Jude Medical2025-06-20
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S095)St Jude Medical2025-05-06
Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable (P960016/S092)St Jude Medical2025-04-10
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S093)St Jude Medical2025-04-10
TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092)St Jude Medical2024-11-27
TactiCath Ablation Catheter, Sensor Enabled (P130026/S091)St Jude Medical2024-11-22
TactiCath Contact Force Ablation Catheter (P130026/S090)St Jude Medical2024-10-09