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510(k) K961155

SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 by Douglas Medical Products Corp. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1996
Date Received
March 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Douglas Medical Products Corp.

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  • K954428 — SOLOPICC 24 (60CM) 20GA CATHETER (March 28, 1996)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942101 — 4-LEAD IRRIGATION SET (September 30, 1994)
  • K941453 — CHECK VALVE SOLUTION SET (August 16, 1994)
  • K930854 — SOLUTION SET WITH .2 MICRON FILTER (January 14, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

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