NA
- Primary DI
- 00763000747466
- Company
- MEDTRONIC, INC.
- Model
- C320LBBL48
- Device description
- CATHETER C320LBBL48 LARGE CURVE 48 GBL
- Published
- 2026-02-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000747466 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00763000747466 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| DQY | Catheter, Percutaneous | 2 | Cardiovascular | 870.1250 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K253409 | 000 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 | DQY |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Working Length | 48 Centimeter | |
| Device Size Text, specify | 0 | Guide catheter dilator inner diameter 0.97 mm (2.9 |
| Device Size Text, specify | 0 | Guide catheter dilator outer diameter 1.73 mm (5.2 |
| Device Size Text, specify | 0 | Guide catheter dilator usable length 56.5 cm |
| Device Size Text, specify | 0 | Guide catheter inner diameter 1.83 mm (5.5 Fr) |
| Device Size Text, specify | 0 | Guide catheter outer diameter 2.34 mm (7.0 Fr) |
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
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