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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K172468
Device Name 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
Applicant
InNeuroCo, Inc
4635 NW 103rd Avenue
Sunrise,  FL  33351
Applicant Contact Marc Litzenberg
Correspondent
InNeuroCo, Inc
4635 NW 103rd Avenue
Sunrise,  FL  33351
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Codes
DTL   GCC  
Date Received08/15/2017
Decision Date 12/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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