# K071226: 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Jun 29, 2007 after 57 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961999 (1996). 5 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971572: Vista Brite Tip Catheters, Cordis Corp. (1997) Summary page 1.
- K980453: Schneider Guider Softip Guiding Catheters, Boston Scientific Scimed, Inc. (1998) Summary page 1.
- K020028: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX, Boston Scientific (2002) Summary page 1.

## Most influential descendants
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System (2014), 17 descendants of its own
- K181642: B-Laser Atherectomy System (2018), 8 descendants of its own
- K202835: Auryon Atherectomy System (2020), 6 descendants of its own

## Recalls of this device
- Jul 18, 2011 · Not classified · Z-2952-2011: Packaging integrity may be compromised, thus sterility can not be assured.
- Jul 18, 2011 · Not classified · Z-2951-2011: Packaging integrity may be compromised, thus sterility can not be assured.

## Indications for use
The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. Not for use in the carotid and coronary vasculature.

Source page: https://510kreport.com/device/K071226
Methodology: https://510kreport.com/methodology