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Flextome® Cutting Balloon®

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Flextome® Cutting Balloon® FDA UDI
Generic Name
Coronary angioplasty balloon catheter, cutting/scoring FDA UDI
Device Name
Microsurgical Dilatation Device FDA UDI
Model / Reference
H749CBM3275100 FDA UDI
Description
Microsurgical Dilatation Device FDA UDI

Identifiers

Catalog Number
H749CBM3275100 FDA UDI
Primary DI / UDI-DI
08714729808343 FDA UDI
PMA Number
P950020 FDA UDI
FDA Product Code
NWX FDA UDI
GMDN Term
Coronary angioplasty balloon catheter, cutting/scoring FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

Flextome® Cutting Balloon® by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P950020 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 96f4ec6b-2689-4787-a67d-72e752216072 37 fields · synced Jun 6, 2026