AngioSculpt® PTCA Scoring Balloon Catheter
GUDID M370202735151D
Angioscore Inc.
Coronary angioplasty balloon catheter, basic| Primary Device ID | M370202735151D |
| NIH Device Record Key | a7d53ffb-fee3-4806-851b-87cea57dd4b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioSculpt® PTCA Scoring Balloon Catheter |
| Version Model Number | 2027-3515 |
| Company DUNS | 615286726 |
| Company Name | Angioscore Inc. |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M370202735151D [Primary] |
FDA Product Code
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-02-12 |
On-Brand Devices [AngioSculpt® PTCA Scoring Balloon Catheter]
Trademark Results [AngioSculpt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIOSCULPT 78263821 2920010 Live/Registered |
AngioScore, Inc. 2003-06-18 |
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