Home / 510(k) Clearances / K871075

510(k) K871075

SCMT UMBILICAL CLAMP by Salt Creek Medical Technologies — Product Code HFW

K871075 is an FDA 510(k) premarket notification submitted by Salt Creek Medical Technologies for the device "SCMT UMBILICAL CLAMP". The FDA issued a decision of Substantially Equivalent on March 23, 1987. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Salt Creek Medical Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Umbilical
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Salt Creek Medical Technologies

  • K864683 — NEONATAL FEEDING KIT (April 17, 1987)
  • K871042 — URINE METER, 250CC (March 25, 1987)
  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K864296 — S.C.T. MULTI PORT, INJECTION SITE (March 2, 1987)
  • K864682 — SALT CREEK P.I. TRAY (January 6, 1987)
  • K864692 — EXTENSION SETS (December 18, 1986)
  • K864693 — I.V. START KITS (December 16, 1986)

Other clearances for product code HFW

  • K041332 — JOEY CLAMP OPENING TOOL (June 25, 2004)
  • K033846 — KAEN YIH UMBILICAL CORD CLAMP (March 11, 2004)
  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER (April 29, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K011621 — KOALA CLAMP, KOALA CLAMP AND CUTTER (August 10, 2001)
  • K010695 — KOALA CLAMP (May 3, 2001)
  • K010835 — POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLA (April 30, 2001)
  • K000227 — UMBICUT (April 27, 2000)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)

FDA data resources