CardiaGuide™ FCL20100
GUDID 00884450504789
Merit Medical Systems, Inc.
Cardiac transseptal access set| Primary Device ID | 00884450504789 |
| NIH Device Record Key | f96ba8b3-8927-4bbf-bccb-d16f5236b033 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardiaGuide™ |
| Version Model Number | 00884450504789 |
| Catalog Number | FCL20100 |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
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 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450504789 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132720
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 | 2021-09-02 |
| Device Publish Date | 2021-08-25 |
On-Brand Devices [CardiaGuide™]
| 00884450504819 | 00884450504819 |
| 00884450504796 | 00884450504796 |
| 00884450504789 | 00884450504789 |
| 00884450504802 | 00884450504802 |
Trademark Results [CardiaGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIAGUIDE 88249990 not registered Live/Pending |
Biosense Webster, Inc. 2019-01-04 |
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