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510(k) K221339

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection by Contego Medical, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
May 9, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Contego Medical, Inc.

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  • K221204 — Excipio SV Thrombectomy Device (June 23, 2022)
  • K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Prote (December 6, 2018)
  • K181128 — Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (September 6, 2018)

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