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510(k) K150800

Valved Safety Centesis Catheter by B.Braun Medical, Inc. — Product Code GCB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2015
Date Received
March 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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Other clearances for product code GCB

  • K974146 — PARACENTESIS CATHETER DEVICE (January 28, 1998)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K923028 — TURKEL PNEUMOTHORAX KIT (August 4, 1992)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)