FDA UDI
In Commercial Distribution
🇺🇸 United States
PulseSelect™
DI: 00763000617554
·
Model: PSCC100
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PulseSelect™
- Primary DI
- 00763000617554
- Version / Model
- PSCC100
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 2
- Public Version Date
- 2024-10-02
- Public Version Status
- Update
- Public Device Record Key
- 4dff35c2-4fb0-4b5d-bc29-f35a6dfcaf55
Device Description
CATHETER PSCC100 PULSESELECT US 25MM
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65066 | Cardiac irreversible electroporation system catheter | A flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is designed to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000617554 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230017 | 000 |
| P230017 | 003 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip Outer Diameter 3.25in (9.8 Fr) | ||
| Device Size Text, specify | Electrode Spacing 3.75mm | ||
| Device Size Text, specify | Electrode Length 3.0mm | ||
| Device Size Text, specify | Working Length Outer diameter 3mm (9 Fr) | ||
| Catheter Working Length | 99.0 | Centimeter | |
| Device Size Text, specify | Loop Outer Diameter 25mm | ||
| Catheter Length | 145.0 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry