Home / 510(k) Clearances / K933763

510(k) K933763

SAVE-T-BREATH AMBILICAL CORD CLAMP by Save-T-Breath Distributors C.C. — Product Code HFW

K933763 is an FDA 510(k) premarket notification submitted by Save-T-Breath Distributors C.C. for the device "SAVE-T-BREATH AMBILICAL CORD CLAMP". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Save-T-Breath Distributors C.C. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1994
Date Received
August 3, 1993
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 Save-T-Breath Distributors C.C.

  • K933762 — STB YANKAUER SUCKER/NOZZLE (July 19, 1994)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)

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