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510(k) K874959

VASCULAR CLAMP by Solway, Inc. — Product Code HXD

K874959 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "VASCULAR CLAMP". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)

Other clearances for product code HXD

  • K890371 — INTESTINAL CRUSHING CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K872386 — C CLAMP (July 2, 1987)
  • K863653 — SUCTION-OFF (October 7, 1986)
  • K853538 — CANNULA CLAMP (September 12, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

FDA data resources