# K973007: Datascope's 10 FR. Flexisheath Percutaneous Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Nov 6, 1997 after 85 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790775 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820834: Percor Percutaneous Introducer, Datascope Corp. (1982) Summary page 1.
- K902674: Datascope Arterial Cannula W/Access Port, Datascope Corp. (1991) Summary page 1.
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 1.
- K940092: Usci Input Introducer Set, Usci, Div. C.R. Bard, Inc. (1995) Summary page 1.
- K940178: Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic Balloon Modification, Datascope Corp. (1994) Summary page 2.
- K940231: Intra-Aortic Balloon for Optional Sheathless Insertion, Datascope Corp. (1994) Summary page 2.
- K943896: Guide Wire for the Use with Datascope Percor Stat-DL Iabs, Datascope Corp. (1995) Summary page 2.
- K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0, Datascope Corp. (1997) Summary page 2.

## Indications for use
Datascope’s 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope’s 9.5Fr. Intra-Aortic Balloon Catheters.

Source page: https://510kreport.com/device/K973007
Methodology: https://510kreport.com/methodology