Carrier™ Delivery Catheter
Basic Information
- Brand Name
- Carrier™ Delivery Catheter
- Primary DI
- 00810068561944
- Version / Model
- CR7071
- Catalog Number
- N/A
- Company Name
- BALT USA LLC
- Labeler DUNS
- 945543689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-07
- Public Version
- 1
- Public Version Date
- 2023-11-15
- Public Version Status
- New
- Public Device Record Key
- 1535023a-b7a0-4515-8177-e404a6300e08
Device Description
The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810068561944 | GS1 |
Customer Contacts
- Phone
- 1-949-788-1443
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230609 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 152 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled