NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
FDA 510(k) K220171 · Northeast Scientific, Inc.
510(k) numberK220171
Submission
- Device name
- NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
- Applicant
- Northeast Scientific, Inc.
Waterbury, CT, US - Received
- January 21, 2022
- Decision date
- July 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QTF – Reprocessed Atherectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
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| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS CatheterOBJ · Traditional | 06/22/2020SE |
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| K060676 | Nes Reprocessed Endoscopic TrocarNLM · Traditional | 09/07/2007SE |
Questions and answers
When was NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter cleared by the FDA?
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (K220171) received a 510(k) decision of Substantially Equivalent on July 1, 2022, 161 days after the submission was received.
What is the product code of K220171?
The FDA product code is QTF – Reprocessed Atherectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.4875.