# K912645: Atriums PDR Thoracic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Sep 13, 1991 after 88 days
- Product code: GBS (Catheter, Ventricular, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973472: 3M Cdi H/S Cuvettes with Heparon Treatment (1997), 0 descendants of its own

## Recalls of this device
- May 12, 2008 · Not classified · Z-1831-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1839-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1837-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1842-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1838-2008: Heparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1843-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1844-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1833-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1841-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1830-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1834-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1845-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1836-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1835-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1846-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1832-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- May 12, 2008 · Not classified · Z-1840-2008: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

Source page: https://510kreport.com/device/K912645
Methodology: https://510kreport.com/methodology