DeviceClearance

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM— 510(k) K994216

Substantially Equivalent

Sims Deltec, Inc.

FDA 510(k) clearance K994216 for PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM, Substantially Equivalent on 2000-01-27. Applicant: Sims Deltec, Inc.. Device class: 2.

Clearance details

Applicant
Sims Deltec, Inc.
Product code
Code LJT
Device class
Class 2
Regulation
21 CFR 880.5965
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LJT

product code LJT
Death
234
Injury
6,468
Malfunction
5,326
Other
2
Total
12,030

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K994216

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994216.

Data sourced from openFDA. This site is unofficial and independent of the FDA.