Peregrine System™ Infusion Catheter
GUDID 00862468000356
Peregrine System™ Infusion Catheter (3-4 mm), 510k, US
ABLATIVE SOLUTIONS, INC.
Peripheral vascular intervention infusion catheter| Primary Device ID | 00862468000356 |
| NIH Device Record Key | 7b2ea29b-209f-441a-ad50-d62cb5b5fd76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peregrine System™ Infusion Catheter |
| Version Model Number | FG32112 |
| Company DUNS | 078293273 |
| Company Name | ABLATIVE SOLUTIONS, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
| Length | 86 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.077 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862468000356 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231279
FDA Product Code
| KRA | Catheter, Continuous Flush |
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 | 2024-03-06 |
| Device Publish Date | 2024-02-27 |
On-Brand Devices [Peregrine System™ Infusion Catheter ]
| 00862468000356 | Peregrine System™ Infusion Catheter (3-4 mm), 510k, US |
| 00862468000349 | Peregrine System™ Infusion Catheter (4-7 mm), 510k, US |
Trademark Results [Peregrine System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEREGRINE SYSTEM 85746944 5013150 Live/Registered |
Ablative Solutions, Inc. 2012-10-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.