510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881493Substantially Equivalent

Port-a-Cath Implantable Access System - Kit Conf.

Pharmacia Deltec, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881493 is the FDA 510(k) clearance record for PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF., a class II device, cleared for Pharmacia Deltec, Inc. on under FDA product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular). FDA records list 43 510(k) clearances for Pharmacia Deltec, Inc., from to . As of , FDA records show no recalls naming K881493.

Clearance record

Decision date
Received
(42 days to decision)
Product code
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Pharmacia Deltec, Inc. 1265 Grey Fox Rd., St. Paul MN
Third party review
No

Clearances, product code LKG

Trailing 12 months

FDA records hold no clearances under product code LKG in the trailing twelve months.

FDA records show no clearances under product code LKG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260