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510(k) K013919

TORFLEX TRANSSEPTAL GUIDING SHEATH by Baylis Medical Co., Inc. — Product Code DBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2002
Date Received
November 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fab, Rhodamine, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5520
Review Panel
IM
Submission Type

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  • K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (August 10, 2010)
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  • K092877 — INDISCAL ASPIRATION DEVICE AND ACCESSORIES (November 17, 2009)
  • K092337 — PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (October 16, 2009)
  • K073326 — NRG TRANSSEPTAL NEEDLE (May 28, 2008)

Other clearances for product code DBY

  • K022067 — CONVOY ADVANCED DELIVERY SHEATH (September 11, 2002)
  • K013304 — BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (January 2, 2002)
  • K013282 — GORE INTRODUCER SHEATH (December 14, 2001)
  • K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT (December 14, 2001)
  • K771144 — RHODAMINE-CONJUGATED ANTISERUM (July 14, 1977)