# K943919: 9.5 FR Sensation DL Intra-Aortic Ballon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 23, 1995 after 223 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.
24 later devices descend from it; 3 cite it directly.
5 of 25 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
- K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 (1997), 20 descendants of its own
- K972113: 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel (1997), 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/K943919
Methodology: https://510kreport.com/methodology