# K220171: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Northeast Scientific, Inc.
- Decided: Jul 1, 2022 after 161 days
- Product code: QTF (Reprocessed Atherectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K890505 (1989). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170059: Spectranetics Turbo-Elite Laser Atherectomy Catheters, Spectranetics, Inc. (2017) Summary page 5.

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0018-2026: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

## Indications for use
The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014”guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014” Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Source page: https://510kreport.com/device/K220171
Methodology: https://510kreport.com/methodology