Atlas FDA

MATRIX STRETCH RESISTANT DETACHABLE COIL

FDA 510(k) clearance K031168 · decided 2003-05-14

Clearance details

K-number
K031168
Device name
MATRIX STRETCH RESISTANT DETACHABLE COIL
Applicant
Boston Scientific, Target
Decision
Substantially Equivalent
Date received
2003-04-14
Decision date
2003-05-14
Days to decision
30 days
Clearance type
Special
Product code
HCG
Device class
2
Regulation number
882.5950
Medical specialty
Neurology
Advisory committee
Neurology
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
Target Xtra Detachable Coil (K261772)Stryker Neurovscular2026-06-24
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351)MicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
Optima Coil System (OptiOne Coil System) (K254221)Balt USA, LLC2026-01-27
Target Detachable Coil (K252694)Stryker Neurovascular2025-12-11
InZone IST Detachment System; IZDS Connecting Cable (K251832)Stryker Neurovascular2025-10-17
Optima Coil System (Optima Packing Coil System) (K252700)Balt USA, LLC2025-09-26
Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30
Optima Coil System (OptiBlock Line Extension) (K242582)Balt USA, LLC2024-09-27
Target Detachable Coils (K242243)Stryker Neurovscular2024-08-29
Numen Coil Embolization System; NumenFR Detachment System (K232955)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10
Axium Detachable Coil; Axium Prime Detachable Coil (K233420)Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular2023-11-07
Penumbra LP Coil System (K230284)Penumbra, Inc.2023-10-25

Recalls involving this device

RecordFirmDate
Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain recall (Z-0854-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certai recall (Z-0855-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intr recall (Z-0856-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certa recall (Z-0857-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intrac recall (Z-0858-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain in recall (Z-0859-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certai recall (Z-0860-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intra recall (Z-0861-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of c recall (Z-0862-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05
Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certa recall (Z-0863-2011)Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 945382011-01-05