# K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: May 1, 1998 after 88 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: 3 generations back to K892222 (1990). 34 ancestors in all.
17 later devices descend from it; 2 cite it directly.
5 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790775: Intra-Aortic Balloon, Type S, Datascope Corp. (1979) Summary page 2.
- K905056: Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat, Datascope Corp. (1991) Summary page 2.
- K910997: Datascope Percor Stat Intra-Aortic Balloon, Datascope Corp. (1991) Summary page 2.
- K911000: Percor Stat DL 8.5 FR 40CC Intra-Aortic Balloon, Datascope Corp. (1993) Summary page 2.
- K914802: Datascope Percor Stat DL9.5 FR34CC Intra-Aort Ball, Datascope Corp. (1993) Summary page 2.
- 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.
- K960166: Percor Stat-DL 9.5 FR. 34 & 40CC, Datascope Corp. (1996) Summary page 2.
- K960713: 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.Sheath), Arrow Intl., Inc. (1996) Summary page 2.
- K961358: Arrow Sheathless Intra-Aortic Balloon Catheter, Arrow Intl., Inc. (1996) Summary page 2.
- K963865: 8 FR. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number Iab-04830S, Arrow Intl., Inc. (1997) 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.
- K972113: 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel, Boston Scientific Corp (1997) Summary page 2.
- K820834: Percor Percutaneous Introducer, Datascope Corp. (1982) Summary page 3.
- K902674: Datascope Arterial Cannula W/Access Port, Datascope Corp. (1991) Summary page 3.
- K904476: Vessel Dilator, Datascope Corp. (1990) Summary page 3.
- K904477: Guidewire, Datascope Corp. (1990) Summary page 3.
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 3.
- K943896: Guide Wire for the Use with Datascope Percor Stat-DL Iabs, Datascope Corp. (1995) Summary page 3.
- K955785: TS Percutaneous Arterial/Venus Catheter Intro Set, C.R. Bard, Inc. (1996) Summary page 3.
- K952430: Finesse Guidewire Coronary, Flexmedics (1995) Summary page 3.
- K960563: Scimed Sceptor & Sceptor Exchange Ptca Guide Wires, Scimed Life Systems, Inc. (1996) Summary page 3.
- K961445: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil, Terumo Medical Corp. (1996) Summary page 3.
- K970994: Core and Coil Assembly Guidewire, Lake Region Mfg., Inc. (1997) Summary page 4.

## Most influential descendants
- 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
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own

## Indications for use
Refractory ventricular failure. Cardiogenic shock. Unstablei refractory angina. Impending infarction. Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture. Ischemia related intractable ventricular arrhythmias. Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients. Septic shock. Weaning from cardiopulmonary bypass. Intraoperative pulsatile flow generation. Support for failed angioplasty and valvuloplasty.

Source page: https://510kreport.com/device/K980385
Methodology: https://510kreport.com/methodology