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510(k) K013174

PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, by Porges S.A. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2002
Date Received
September 24, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Porges S.A.

  • K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, (October 17, 2002)
  • K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (October 17, 2002)
  • K013172 — PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, (December 20, 2001)
  • K900269 — PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE (July 3, 1990)
  • K900031 — MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS (March 6, 1990)
  • K896503 — PORGES ERCP CATHETERS (January 30, 1990)
  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896425 — PORGES CYTOLOGY BRUSHES (January 29, 1990)
  • K896507 — PORGES DIATHERMY SNARE (January 29, 1990)
  • K896424 — PORGES SCLEROTHERAPY NEEDLES (January 26, 1990)

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