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510(k) K954619

CORDGUARD II by Utah Medical Products, Inc. — Product Code KNA

K954619 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "CORDGUARD II". The FDA issued a decision of Substantially Equivalent on December 21, 1995. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1995
Date Received
October 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Utah Medical Products, Inc.

  • K143424 — UTAH CVX-RIPE (August 28, 2015)
  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K101535 — BT-CATH (January 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)

Other clearances for product code KNA

  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 2014)
  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (April 14, 2010)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (October 27, 2006)
  • K060289 — EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (July 7, 2006)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K014248 — DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (March 21, 2002)
  • K001590 — DND 101 (August 2, 2000)
  • K990738 — DR. JAHANGER'S CUTTER (October 29, 1999)

FDA data resources