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510(k) K061766

EXPRESSWAY INTERMITTENT CATHETER by Percutaneous Systems, Incorporated — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2007
Date Received
June 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Percutaneous Systems, Incorporated

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  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)
  • K052048 — ACCORDION (September 13, 2005)
  • K042531 — UPDATED SLIP UROLOGY INTRODUCER SHEATH (February 1, 2005)

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