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510(k) K925161

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO by North American Sterilization & Packaging Co. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
October 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by North American Sterilization & Packaging Co.

  • K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (March 10, 1997)
  • K963753 — NASP TRANSPARENT DRESSING (November 29, 1996)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (December 3, 1993)
  • K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION (December 3, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K910691 — NORTEC URETERAL STENT (August 15, 1991)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)
  • K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES (December 18, 1990)

Other clearances for product code KNY

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  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)