Atlas FDA

MERIDIAN GUIDEWIRE

FDA 510(k) clearance K093681 · decided 2010-01-26

Clearance details

K-number
K093681
Device name
MERIDIAN GUIDEWIRE
Applicant
Ev3 Neurovascular
Decision
Substantially Equivalent
Date received
2009-11-27
Decision date
2010-01-26
Days to decision
60 days
Clearance type
Traditional
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, 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
Accoat Guide Wire (K253667)Sp Medical A/S2026-07-14
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FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (K260544)FMD Co., Ltd.2026-03-20
Enroute 0.014'' Transcarotid Guidewire (K253746)Lake Region Medical2026-03-19
EmeryGlide™ (EG18008901) (K253262)Nano4imaging GmbH2026-03-06
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (K253847)Merit Medical Ireland, Ltd.2026-01-31
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) (K251385)Merit Medical Ireland, Ltd.2026-01-21
Solo Pace Fusion System (SOLOFUSE1) (K252674)Solo Pace, Inc.2026-01-09
Lunderquist Extra Stiff Wire Guide (K251596)William Cook Europe Aps2025-11-09
SureAx-Guide™ (K250203)Sureax Medical, LLC2025-10-17
Amplatzer Guidewire (K250031)ABBOTT MEDICAL2025-10-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Onyx Liquid Embolic System (LES) (P030004/S035)Ev3 Neurovascular2025-12-08
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S037)Ev3 Neurovascular2024-12-19
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S036)Ev3 Neurovascular2024-11-07
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S034)Ev3 Neurovascular2024-09-20
Onyx™ Liquid Embolic System (P030004/S033)Ev3 Neurovascular2024-07-26
Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm (P030004/S031)Ev3 Neurovascular2024-04-16
Onyx™ Liquid Embolic System (P030004/S030)Ev3 Neurovascular2023-11-03
Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm (P030004/S029)Ev3 Neurovascular2022-07-28