ClearanceBrief
Panels › Cardiovascular › Product code QTF · Class 2

Reprocessed Atherectomy Catheter

Regulation 870.4875

0510(k)s in 12 months (1 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
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Top companies in QTF

Company510(k)sRecalls
Northeast Scientific, Inc.18
DateFirm and productCodeLinked 510(k)
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including a
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, inc
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, includin
Open, Classified
QTFNone listed
Oct 2, 2025Northeast Scientific Inc.
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including
Open, Classified
QTFK220171

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