Atlas FDA

TRANSGATE GUIDE CATHETER

FDA 510(k) clearance K132542 · decided 2013-11-15

Clearance details

K-number
K132542
Device name
TRANSGATE GUIDE CATHETER
Applicant
Stryker Neurovascular
Decision
Substantially Equivalent
Date received
2013-08-13
Decision date
2013-11-15
Days to decision
94 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fremont, CA, 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
CPS Locator 3D Plus Delivery Catheter (K261766)CenterPoint Systems, LLC2026-07-29
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Amplatzer TorqVue Exchange System (K261631)Abbott Medical2026-06-17
Perfect-O Ostial Positioning Catheter (K260289)Balosmark, Inc.2026-06-05
Amplatzer TorqVue Delivery System (K260993)Abbott2026-04-24
Teleport Glide Microcatheter (K253361)OrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409)Medtronic, Inc.2025-12-19
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417)ABBOTT MEDICAL2025-12-17
Telescope Guide Extension Catheter (K252390)Medtronic, Ireland2025-10-29
CPS Locator 3D Delivery Catheter (K250147)Centerpoint Systems2025-08-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Surpass Streamline Flow Diverter (P170024/S024)Stryker Neurovascular2025-08-20
Neuroform Atlas® Stent System (P180031/S006)Stryker Neurovascular2025-06-24
Surpass Streamline Flow Diverter (P170024/S023)Stryker Neurovascular2025-05-30
Neuroform Atlas Stent System (P180031/S011)Stryker Neurovascular2025-05-09
Surpass Elite Flow Diverter System (P170024/S022)Stryker Neurovascular2025-02-12
Neuroform Atlas Stent System (P180031/S010)Stryker Neurovascular2024-12-09
Neuroform Atlas Stent System (P180031/S009)Stryker Neurovascular2024-11-18
Surpass Elite Flow Diverter System (P170024/S018)Stryker Neurovascular2024-10-16