Atlas FDA

VASCON NEUROPATH GUIDING CATHETER

FDA 510(k) clearance K052004 · decided 2006-01-19

Clearance details

K-number
K052004
Device name
VASCON NEUROPATH GUIDING CATHETER
Applicant
Vascon, LLC
Decision
Substantially Equivalent
Date received
2005-07-25
Decision date
2006-01-19
Days to decision
178 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Coral Springs, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronar recall (Z-0842-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary recall (Z-0843-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary recall (Z-0844-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronar recall (Z-0845-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronar recall (Z-0846-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the corona recall (Z-0847-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary recall (Z-0848-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronar recall (Z-0849-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronar recall (Z-0850-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronar recall (Z-0851-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronar recall (Z-0852-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronar recall (Z-0853-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronar recall (Z-0854-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronar recall (Z-0855-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronar recall (Z-0856-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronar recall (Z-0857-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronar recall (Z-0858-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary recall (Z-0859-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary recall (Z-0860-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary recall (Z-0861-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronar recall (Z-0862-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary recall (Z-0863-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronar recall (Z-0864-2013)Codman & Shurtleff, Inc.2013-02-20
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronar recall (Z-0865-2013)Codman & Shurtleff, Inc.2013-02-20