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NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Model / Reference
- R-420-006 FDA UDI
Identifiers
- Catalog Number
- R-420-006 FDA UDI
- Primary DI / UDI-DI
- 00850044399079 FDA UDI
- 510(k) Number
- K220171 FDA UDI
- FDA Product Code
- QTF FDA UDI
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 150 Centimeter FDA UDILumen/Inner Diameter — 0.018 Inch FDA UDIIntroducer Sheath Compatibility — 6 French FDA UDI
Category: Atherectomy laser system beam guide-catheter, peripheral
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Atherectomy laser system beam guide-catheter, peripheral.
- Turbo-Elite™ — Spectranetics Corporation · Class II
- Auryon Laser System 100-120 Vac — EXIMO MEDICAL LTD · Class II
- Auryon Atherectomy Catheter — EXIMO MEDICAL LTD · Class II
- DABRA 101 Catheter — Catheter Precision, Inc · Class II
- Turbo-Power™ — Spectranetics Corporation · Class II
- Auryon Atherectomy Catheter 2.0 mm OTW — EXIMO MEDICAL LTD · Class II
- Auryon Atherectomy Catheter — EXIMO MEDICAL LTD · Class II
- Turbo-Elite™ — Spectranetics Corporation · Class II
Cleared under the same submission
K220171 also covers:
- NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Northeast Scientific, Inc.
Sources (1)
- FDA UDI 4c23f696-aba2-4fa4-a5be-02540e0ff5ca 36 fields · synced May 30, 2026