# K963865: 8 FR. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number Iab-04830S

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 16, 1997 after 357 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
Longest line of descent: 1 generation back to K961358 (1996). 1 ancestor in all.
18 later devices descend from it; 1 cites it directly.
5 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961358: Arrow Sheathless Intra-Aortic Balloon Catheter, Arrow Intl., Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K951358: Sireskop SX, Siemens Medical Solutions USA, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories (1998), 17 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
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), 14 descendants of its own
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX (2003), 12 descendants of its own
- K041281: Datascope 7.5FR. Iab Catheter and Accessories (2004), 11 descendants of its own

## Indications for use
Refractory left ventricular power failure. Cardiogenic shocl/unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepkal defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

Source page: https://510kreport.com/device/K963865
Methodology: https://510kreport.com/methodology