# K960713: 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.Sheath)

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: May 15, 1996 after 84 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
10 of 31 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
- K963920: 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter, (1997), 19 descendants of its own
- K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840 (2002), 18 descendants of its own
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 descendants of its own
- K980780: Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles (1998), 16 descendants of its own
- K994157: Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (2000), 15 descendants of its own

Source page: https://510kreport.com/device/K960713
Methodology: https://510kreport.com/methodology