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510(k) K811068

BYPASS COIL by G.D. Searle and Co. — Product Code KPY

K811068 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "BYPASS COIL". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1981
Date Received
April 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)
  • K802280 — WHITE KNIGHT DRAPE SEAL (October 10, 1980)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)

FDA data resources