FlexCath Advance™
GUDID 00763000953461
SHEATH 4FC12 FLEXCATH ADVANCE 12F US
MEDTRONIC, INC.
Haemostasis valve| Primary Device ID | 00763000953461 |
| NIH Device Record Key | a4e9db40-2e97-438f-aea1-4eceafce0473 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexCath Advance™ |
| Version Model Number | 4FC12 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | false |
| 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(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
| Length | 65 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000953461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202620
FDA Product Code
| DRA | CATHETER, STEERABLE |
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 | 2025-09-15 |
| Device Publish Date | 2025-09-06 |
On-Brand Devices [FlexCath Advance™]
| 00643169688872 | SHEATH 4FC12 FLEXCATH ADVANCE 12F US |
| 00763000043773 | SHEATH 4FC12 FLEXCATH ADVANCE 12F US |
| 00763000279905 | SHEATH 990065 FLEXCATH SELECT 10 FR 65CM |
| 00763000217136 | SHEATH 4FC12 FLEXCATH ADVANCE 12F US |
| 00763000418052 | SHEATH 4FC12 FLEXCATH ADVANCE 12F US |
| 00763000953461 | SHEATH 4FC12 FLEXCATH ADVANCE 12F US |
Trademark Results [FlexCath Advance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXCATH ADVANCE 85476216 4667896 Live/Registered |
Medtronic CryoCath LP 2011-11-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.