FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
K Number: K223369
·
Decision Dec 2, 2022
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
204
Review Days
28
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Basic Information
- Device Name
- truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
- K Number
- K223369
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- November 4, 2022
- Decision Date
- December 2, 2022
- Product Code
- GEH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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