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510(k) K851834

MANAN GWI GUIDE WIRE INTRODUCER by Manan Manufacturing Co., Inc. — Product Code DWS

K851834 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN GWI GUIDE WIRE INTRODUCER". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
April 26, 1985
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 Manan Manufacturing Co., Inc.

  • K873208 — MANAN TURNER STYLE NEEDLE (August 25, 1987)
  • K864405 — MANAN CONTRAST MEDIA ADMINISTRATION SET (December 18, 1986)
  • K863848 — MANAN BREST TUMOR LOCALIZATION NEEDLE (October 14, 1986)
  • K852018 — ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR (July 11, 1985)
  • K852501 — MYELOGRAM PROCEDURE TRAY (July 11, 1985)
  • K851832 — NAMAN POTTS COURNAND NEEDLE (July 11, 1985)
  • K851833 — MANAN SELDINGER NEEDLE (July 11, 1985)
  • K852427 — MANAN SPINAL NEEDLE (June 27, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE (June 27, 1985)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources