Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
FDA 510(k) clearance K202459 · decided 2021-09-26
Clearance details
- K-number
- K202459
- Device name
- Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
- Applicant
- Pharma System AB
- Decision
- Substantially Equivalent
- Date received
- 2020-08-27
- Decision date
- 2021-09-26
- Days to decision
- 395 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Knivsta, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.