Ablacon™ Mapping Catheter
GUDID 00860457001544
The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These signals may be used for analysis with mapping systems. The Ablacath™ Mapping Catheter may also be used to deliver externally generated pacing stimuli.
Ablacon Inc.
Cardiac mapping catheter, percutaneous, single-use| Primary Device ID | 00860457001544 |
| NIH Device Record Key | d22bf759-ba54-4c7a-8982-071d2f5e5eab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ablacon™ Mapping Catheter |
| Version Model Number | AB-0003-50 |
| Company DUNS | 106083214 |
| Company Name | Ablacon 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 | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com | |
| Phone | 303-995-5620 |
| contact@ablacon.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860457001544 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223666
FDA Product Code
| MTD | Catheter, Intracardiac Mapping, High-Density Array |
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 | 2023-12-15 |
| Device Publish Date | 2023-12-07 |
On-Brand Devices [Ablacon™ Mapping Catheter]
| 00860457001551 | The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardia |
| 00860457001544 | The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardia |
Trademark Results [Ablacon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABLACON 79177941 4986017 Live/Registered |
Ablacon Inc. 2015-09-10 |
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