Identity
- Trade Name
- ProCatid System kit Finished Good FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039 FDA UDI
- Model / Reference
- P2-9-0705-S FDA UDI
- Description
- The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039 FDA UDI
Identifiers
- Catalog Number
- P2-9-0705-S FDA UDI
- Primary DI / UDI-DI
- 07290015512015 FDA UDI
- 510(k) Number
- K143570 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Embolic protection filtering guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Embolic protection filtering guidewire
ProCatid System kit Finished Good by Gardia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143570 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gardia Medical
Sources (1)
- FDA UDI 1539c72e-6586-4d99-a5db-76d3f0943b0a 36 fields · synced May 30, 2026