Volcano Corporation

Part number 1400; Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010.

Cardiovascular Devices

2

No

Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe

FloWire Doppler Guide wires. || Volcano Corporation, || Rancho Cardova, Ca. || The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.

Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.

Cardiovascular Devices

Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria

Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.

Software version 3.2, Part Numbers 435-0602.01 to 05,

Radiology Devices

2

No

Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.

Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.

All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02

Radiology Devices

2

No

Worldwide Distribution.

Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. || Medical device for use in imaging of histology.

Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.

Volcano pcFM Software Kit ; || Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. || The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.