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510(k) K990737

'ECURLINE UMBILICAL CORD CLAMP #3500 by Precision Dynamics Corp. — Product Code HFW

K990737 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "'ECURLINE UMBILICAL CORD CLAMP #3500". The FDA issued a decision of Substantially Equivalent on April 6, 1999. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1999
Date Received
March 5, 1999
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 Precision Dynamics Corp.

  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (January 24, 2000)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)
  • K874665 — SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (January 20, 1988)
  • K873369 — SECURLINE FRANSEENE NEEDLE (October 20, 1987)
  • K872507 — PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (July 9, 1987)
  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

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