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510(k) K112629

ONSET ACCESS CATHETER SYSTEM by Onset Medical Corporation — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2011
Date Received
September 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K062852 — BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 (February 23, 2007)
  • K061009 — PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS (May 2, 2006)
  • K043254 — PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (February 10, 2005)

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