← Back to catalogue

Elca™

FDA UDI

Class III (US FDA UDI)

by Spectranetics Corporation

Identity

Trade Name
ELCA™ FDA UDI
Generic Name
Atherectomy laser system beam guide-catheter, coronary FDA UDI
Device Name
ELCA™ Coronary Laser Atherectomy Catheter FDA UDI
Model / Reference
120-008AA FDA UDI
Description
ELCA™ Coronary Laser Atherectomy Catheter FDA UDI

Identifiers

Catalog Number
120-008 FDA UDI
Primary DI / UDI-DI
00813132020071 FDA UDI
PMA Number
P910001 FDA UDI
FDA Product Code
LPC FDA UDI
GMDN Term
Atherectomy laser system beam guide-catheter, coronary FDA UDI

Classification

Device Class
Class III 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
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.0 Millimeter FDA UDI

Category: Atherectomy laser system beam guide-catheter, coronary

Elca™ by Spectranetics Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Atherectomy laser system beam guide-catheter, coronary.

Cleared under the same submission

P910001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spectranetics Corporation

Sources (1)

  • FDA UDI 1bbca2cb-4705-44e9-812b-4b9be75bfb40 38 fields · synced May 30, 2026