enableCV Introducer Sheath

GUDID 00840479401263

Introducer Sheath - IS19A

ENABLECV INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00840479401263
• NIH Device Record Key: 41f8f6bc-83ef-4a61-bbe1-a707b95c5c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enableCV Introducer Sheath
• Version Model Number: IS19A
• Company DUNS: 119247843
• Company Name: ENABLECV 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: 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

Customer Support Contacts

• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com
• Phone: 1(888)943-2783
• Email: customerservice@enablecv.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged device in a cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479401256 [Primary]
GS1	00840479401263 [Package]; Contains: 00840479401256; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972570

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-06
• Device Publish Date: 2026-02-26

Devices Manufactured by ENABLECV INC.

• 00840479401225 - enableCV EndoReturn™ Arterial Cannula: 2026-03-06 EndoReturn™ Arterial Cannula - ER21B
• 00840479401249 - enableCV EndoReturn™ Arterial Cannula: 2026-03-06 EndoReturn™ Arterial Cannula - ER23B
• 00840479401263 - enableCV Introducer Sheath: 2026-03-06Introducer Sheath - IS19A
• 00840479401263 - enableCV Introducer Sheath: 2026-03-06 Introducer Sheath - IS19A
• 00840479400785 - enableCV EZ Glide™ Aortic Cannula: 2026-02-26 enableCV EZ Glide™ Aortic Cannula - EZC24TA
• 00840479400099 - enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula: 2026-02-26 enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula - TRF3646O2A
• 00840479400112 - enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula: 2026-02-26 enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula - TRF3646O2
• 00840479400211 - enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula: 2026-02-26 enableCV Trim-Flex™ Dual Stage Venous Drainage Cannula - TRF2937O
• 00840479400259 - enableCV Dual Stage Venous Drainage Cannula: 2026-02-26 enableCV Dual Stage Venous Drainage Cannula - TR3446L