ELCA™ 120-009
GUDID M204120009AA0
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
Atherectomy laser system beam guide-catheter, coronary| Primary Device ID | M204120009AA0 |
| NIH Device Record Key | 8fa17225-5ad0-4b6c-9a2b-2a9ff7e28ead |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELCA™ |
| Version Model Number | 120-009AA |
| Catalog Number | 120-009 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com | |
| Phone | 1-800-633-0960 |
| complaints@spnc.com |
Device Dimensions
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
| Outer Diameter | 2 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132020088 [Primary] |
| HIBCC | M204120009AA0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P910001
FDA Product Code
| LPC | Device, Angioplasty, Laser, Coronary |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
[M204120009AA0]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-02-06 |
On-Brand Devices [ELCA™]
| 00813132025489 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025472 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025465 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025458 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025441 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025434 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025427 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025410 | ELCA™ Coronary Laser Atherectomy Catheter |
| 00813132025403 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204120009AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204120008AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204117205AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204117016AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204114009AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204110004AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204110003AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204110002AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M204110001AA0 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041200090 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041200080 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041172050 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041170160 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041140090 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100040 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100030 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100020 | ELCA™ Coronary Laser Atherectomy Catheter |
| M2041100010 | ELCA™ Coronary Laser Atherectomy Catheter |
Trademark Results [ELCA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELCA 79312200 not registered Live/Pending |
ELCA S.R.L. 2021-02-26 |
 ELCA 76559839 2906015 Live/Registered |
Evangelical Lutheran Church in America 2003-10-29 |
 ELCA 74247370 1823660 Live/Registered |
SPECTRANETICS CORPORATION, THE 1992-02-13 |
 ELCA 72164677 0770656 Dead/Expired |
ELECTROCHIMICA CORPORATION 1963-03-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.