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510(k) K874960

CARDIOVASCULAR SURGICAL INSTRUMENTS by Solway, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Solway, Inc.

  • 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)
  • K874952 — MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)

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  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
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