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510(k) K122926

SUREFLEX STEERABLE GUIDING SHEATH KIT by Baylis Medical Co., Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2013
Date Received
September 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K101117 — LEV-OR DILATION CATHETER OTW (July 16, 2010)
  • 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)
  • K072478 — BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD (December 19, 2007)

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