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510(k) K954428

SOLOPICC 24 (60CM) 20GA CATHETER by Douglas Medical Products Corp. — Product Code FOZ

K954428 is an FDA 510(k) premarket notification submitted by Douglas Medical Products Corp. for the device "SOLOPICC 24 (60CM) 20GA CATHETER". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Douglas Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
September 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Douglas Medical Products Corp.

  • K162951 — TUBETECH IV Administration Set (July 28, 2017)
  • K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 (June 18, 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)
  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

Other clearances for product code FOZ

  • K260432 — Ruby Intravascular Catheter (September 2, 2026)
  • K260165 — Unimpregnated Central Venous Catheter (August 10, 2026)
  • K261041 — ClearSafe Closed System (July 10, 2026)
  • K260539 — MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (July 9, 2026)
  • K253235 — Introcan Safety® Deep Access XL IV Catheter (May 15, 2026)
  • K252137 — BD Insyte™ IV Catheter (April 2, 2026)
  • K252513 — Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G (April 1, 2026)
  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)

FDA data resources