FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANESTHESIA BREATHING CIRCUIT
K Number: K915452
·
Decision Feb 14, 1992
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
23
Review Days
71
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Basic Information
- Device Name
- ANESTHESIA BREATHING CIRCUIT
- K Number
- K915452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Concord/Portex
- Date Received
- December 5, 1991
- Decision Date
- February 14, 1992
- Product Code
- CAI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAI), ordered by most recent decision date.
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Other Clearances by Concord/Portex
| K Number | Device Name | ||
|---|---|---|---|
| K923559 | STERI-CATH MDI | Oct 25, 1993 | Substantially Equivalent |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Jul 27, 1993 | Substantially Equivalent |
| K924541 | EPIDURAL MINIPACK | Jul 9, 1993 | Unknown |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Jun 22, 1993 | Unknown |
| K923127 | NEEDLE-PRO CARTRIDGE | Apr 29, 1993 | Substantially Equivalent |
| K923910 | HEAT MOISTURE CONDENSER | Jan 26, 1993 | Substantially Equivalent |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Sep 2, 1992 | Substantially Equivalent |
| K922445 | VACU-PRO | Aug 12, 1992 | Substantially Equivalent |
| K911809 | NEW-VENT | Aug 26, 1991 | Substantially Equivalent |
| K912124 | TRACHEOSTOMY TUBE AND CUFF | Aug 16, 1991 | Substantially Equivalent |