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NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K143701
Identity
- Trade Name
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Model / Reference
- R-85900PST FDA UDI
Identifiers
- Primary DI / UDI-DI
- B227HBRK240 FDA UDI
- FDA Product Code
- OWQ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Yes
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
- Guidewire Diameter — 0.014 Inch FDA UDIIntroducer Sheath Compatibility — 5 French FDA UDICatheter Working Length — 150 Centimeter FDA UDI
Category: Intravascular ultrasound imaging catheter, reprocessed
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip by Northeast Scientific, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)
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Also classified as Intravascular ultrasound imaging catheter, reprocessed.
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- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143701 | Class II | Active |
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Manufacturer
- Manufacturer
- Northeast Scientific, Inc.
- FDA Applicant
- Volcano Corporation
Sources (2)
- FDA UDI a51f4db1-c889-42cf-af20-61066037bb17 59 fields · synced Jun 18, 2026
- FDA 510(k) K143701 1 fields · synced May 29, 2026