Home / 510(k) Clearances / K952201

510(k) K952201

PORT-A-CATH ACCESS KIT by Medi-Flex Hospital Products, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1995
Date Received
May 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Medi-Flex Hospital Products, Inc.

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 (September 6, 1996)
  • K952416 — TRACHEOSTOMY CARE KIT (August 9, 1995)
  • K952256 — PICC LINE KIT (July 31, 1995)
  • K952007 — ADHEROL SEPP APPLICATOR (June 8, 1995)
  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K920399 — COMPOUND BENZOIN TINCTURE USP FREPP (January 25, 1994)
  • K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (January 25, 1994)
  • K930196 — CEPTI-SEAL I.V. PREP KIT (July 2, 1993)
  • K921347 — CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (January 8, 1993)

Other clearances for product code FMF

  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K252033 — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (July 25, 2025)