# K822806: Balloon Wedge Pressure, Angiographic

- Pathway: 510(k) (Traditional)
- Applicant: Nova Medical Specialties
- Decided: Nov 1, 1982 after 45 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K012225: Attain 6215 Venogram Balloon Catheter (2001), 1 descendant of its own
- K121219: Attain Clarity 6225 Venogram Balloon Catheter (2012), 0 descendants of its own
- K955829: Safpace System (1997), 0 descendants of its own

## Recalls of this device
- 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/K822806
Methodology: https://510kreport.com/methodology