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510(k) K896676

KEY VASCULAR LOOPS by Key Surgical, Inc. — Product Code KDC

K896676 is an FDA 510(k) premarket notification submitted by Key Surgical, Inc. for the device "KEY VASCULAR LOOPS". The FDA issued a decision of Substantially Equivalent on February 27, 1990. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Key Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
November 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Key Surgical, Inc.

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K151222 — Cautery Tip Cleaner (May 22, 2015)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K896472 — KEY VASCULAR BOOTIES (December 14, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)

FDA data resources