Identity
- Trade Name
- PeriCross Epicardial Access Kit FDA UDI
- Generic Name
- Epicardial catheter introduction set FDA UDI
- Model / Reference
- PC-1013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851498007395 FDA UDI
- 510(k) Number
- K243954 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Epicardial catheter introduction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
No
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: Epicardial catheter introduction set
PeriCross Epicardial Access Kit by CIRCA Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epicardial catheter introduction set.
- EPi-Ease Epicardial Access System — ATRICURE, INC. · Class II
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
- CIRCA Scientific, Inc.
Sources (1)
- FDA UDI afa229f9-9bcd-42e2-b5f8-94cad4f7bcab 33 fields · synced Jun 9, 2026