FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Distal Access Catheter
K Number: K213065
·
Decision May 31, 2022
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
2
Review Days
250
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Distal Access Catheter
- K Number
- K213065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Easycess Medical Co.,Ltd
- Date Received
- September 23, 2021
- Decision Date
- May 31, 2022
- Product Code
- QJP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QJP), ordered by most recent decision date.
BOBBY Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Zenith Distal Access Long Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
SAYA 86 Radial Access Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BosCATH Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Next Generation 088 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PATH BGC
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Guangzhou Easycess Medical Co.,Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K233428 | Easycess Aspiration Pump | Nov 3, 2023 | Substantially Equivalent |