# K832287: Nova Balloon Thermodilution Infusion

- Pathway: 510(k) (Traditional)
- Applicant: Nova Medical Specialties
- Decided: Oct 19, 1983 after 98 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Jun 5, 2007 · Not classified · Z-1116-2007: Cracks at the Catheter Tip
- May 25, 2005 · Not classified · Z-0995-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-0996-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1002-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1003-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1005-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1006-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1013-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-0997-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-0998-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1001-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1007-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1008-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1010-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1012-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1014-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-0999-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1000-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1011-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1004-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- May 25, 2005 · Not classified · Z-1009-05: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

Source page: https://510kreport.com/device/K832287
Methodology: https://510kreport.com/methodology