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510(k) K911070

PICC-FIX by Sorex Medical — Product Code KMK

K911070 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "PICC-FIX". The FDA issued a decision of Substantially Equivalent on July 5, 1991. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Sorex Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Sorex Medical

  • K923843 — FOGLESS (March 25, 1994)
  • K913036 — PLUME MASTER (September 6, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (April 5, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K903740 — TRACH-EZE (December 6, 1990)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • K943147 — STATLOCK CV (September 29, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)

FDA data resources