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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K242756
Device Name Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
Applicant
Pulnovo Medical (Wuxi) Co., Ltd.
3rd Floor, Bldg. D 17, # 1719-17 Huishan Ave., & 3rd Flr, Bl
D 11, # 1719-11, Huishan Ave., Huishan Economic Dev Zone
Wuxi,  CN 214000
Applicant Contact Wen Gu
Correspondent
Pulnovo Medical (Wuxi) Co., Ltd.
3rd Floor, Bldg. D 17, # 1719-17 Huishan Ave., & 3rd Flr, Bl
D 11, # 1719-11, Huishan Ave., Huishan Economic Dev Zone
Wuxi,  CN 214000
Correspondent Contact Wen Gu
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/12/2024
Decision Date 11/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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