# K010330: Arrow Rediguard, 9FR. 50CC, Intra-Aortic Balloon Vatheter, Iab-R950-U

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 2, 2001 after 28 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 13 (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. The FDA summary names its predicate without a number.
- (no number) Arrow RediGuard® 9Fr. 40cc: named in the summary without a submission number
- (no number) Arrow 10Fr. 50cc IABs with a tear away hemostasis device: named in the summary without a submission number

## Recalls of this device
- Feb 2, 2009 · Not classified · Z-1216-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1214-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1219-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1221-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1218-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1210-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1215-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1220-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1217-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1211-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1212-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1222-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1213-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 

## Indications for use
The Arrow Rediguard® 9Fr. 50cc Intra-Aortic Balloon Catheters IAB-R950-U is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

Source page: https://510kreport.com/device/K010330
Methodology: https://510kreport.com/methodology