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Pantera LEO

FDA UDI

Class II (US FDA UDI)

by Biotronik, Inc.

Identity

Trade Name
Pantera LEO FDA UDI
Generic Name
Coronary angioplasty balloon catheter, basic FDA UDI
Model / Reference
2.5/12/145 FDA UDI

Identifiers

Catalog Number
367004 FDA UDI
Primary DI / UDI-DI
07640130415621 FDA UDI
FDA Product Code
LOX FDA UDI
GMDN Term
Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5100 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

Category: Coronary angioplasty balloon catheter, basic

Pantera LEO is a flexible catheter designed for percutaneous transluminal coronary angioplasty (PTCA) to treat narrowed or obstructed coronary arteries. This single-use device features multiple sizes and types, including over-the-wire and rapid exchange designs, making it suitable for various patient needs.

Similar devices

Also classified as Coronary angioplasty balloon catheter, basic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA UDI d35b1397-9291-477a-bad4-30e15b58826e 36 fields · synced Jul 26, 2026