DeviceClearance

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH— 510(k) K983511

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K983511 for SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH, Substantially Equivalent on 1999-06-08. Applicant: Medical Components, Inc.. Device class: 2.

Clearance details

Applicant
Medical Components, Inc.
Product code
Code MPB
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Harleysville, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MPB

view all

More clearances from Medical Components, Inc.

view all

Adverse events under product code MPB

product code MPB
Death
18
Malfunction
1,042
Total
1,060

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 K983511

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 K983511.

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