Atlas FDA

Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter

FDA 510(k) clearance K212588 · decided 2022-05-04

Clearance details

K-number
K212588
Device name
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2021-08-16
Decision date
2022-05-04
Days to decision
261 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tempe, AZ, 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
SSPC NXT Delivery Catheter (K262240)CenterPoint Systems, LLC2026-07-29
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825)Abbott2026-07-02
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
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035)C.R. Bard, Inc.2026-07-15
Covera™ Vascular Covered Stent (P170042/S015)C.R. Bard, Inc.2026-06-10
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04