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510(k) K881493

PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. by Pharmacia Deltec, Inc. — Product Code LKG

K881493 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.". The FDA issued a decision of Substantially Equivalent on May 20, 1988. The device falls under product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular), a Class II device regulated under 21 CFR 882.5550. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1988
Date Received
April 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class
Class II
Regulation Number
882.5550
Review Panel
HO
Submission Type

Other clearances by Pharmacia Deltec, Inc.

  • K943310 — MODEL 6100 AMBULATORY INFUSION SYSTEM (February 21, 1995)
  • K942046 — PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE (October 4, 1994)
  • K942161 — LOCKBOX (August 2, 1994)
  • K942024 — PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (July 26, 1994)
  • K941445 — EXTENSION SET WITH ANTI-SIPHON VALVE (June 29, 1994)
  • K931073 — CATH-FINDER (May 5, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (May 2, 1994)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)

Other clearances for product code LKG

  • K950315 — CORDIS CSF RESERVOIR (May 9, 1995)
  • K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPS (May 20, 1988)
  • K874468 — P-S MEDICAL VENTRICULAR ACCESS PORT (February 11, 1988)
  • K874498 — CSF-VENTRICULOSTOMY RESERVOIR (February 11, 1988)
  • K833822 — P-S MEDICAL CSF ACCESS DEV 15MM/25MM (May 25, 1984)
  • K833672 — HH SUBCUTANEOUS ACCESS PORT (March 6, 1984)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)

FDA data resources