Santreva-ATK Endovascular Revascularization Catheter AS-1963-01

GUDID 00860009199705

The Santreva™-ATK Endovascular Revascularization Catheter is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including Chronic Total Occlusions (CTOs), in the femoropopliteal (arterial) peripheral vasculature.

Angiosafe, Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00860009199705
• NIH Device Record Key: ddd21818-3b6e-47a5-be77-ff621daad1f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Santreva-ATK Endovascular Revascularization Catheter
• Version Model Number: AS-1963-01
• Catalog Number: AS-1963-01
• Company DUNS: 116766212
• Company Name: Angiosafe, 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: true
• Manufacturing Date: true
• 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
GS1	00860009199705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252315

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

[00860009199705]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03