FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOVER LOW PRESSURE TRACHEAL TUBE
K Number: K761258
·
Decision Dec 23, 1976
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
127
Applicant Total
14
Review Days
8
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Basic Information
- Device Name
- DOVER LOW PRESSURE TRACHEAL TUBE
- K Number
- K761258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Will Ross Co.
- Date Received
- December 15, 1976
- Decision Date
- December 23, 1976
- Product Code
- BTO
- 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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
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Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
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BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
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PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
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WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
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Other Clearances by Will Ross Co.
| K Number | Device Name | ||
|---|---|---|---|
| K780850 | SEARLE NEONATAL OXYGEN PROBE | Aug 23, 1978 | Substantially Equivalent |
| K771561 | DOVER URINE METER | Sep 7, 1977 | Substantially Equivalent |
| K771132 | KENWOOD BIOLOGICAL STEOILIZ. INDICATOR | Jul 14, 1977 | Substantially Equivalent |
| K770611 | PARALLEL BARS | Apr 8, 1977 | Substantially Equivalent |
| K770612 | SPLINT, BOHLER | Apr 8, 1977 | Substantially Equivalent |
| K770607 | TRACTION HARNESS | Apr 8, 1977 | Substantially Equivalent |
| K770608 | WALKING AID | Apr 8, 1977 | Substantially Equivalent |
| K770610 | TABLE, TREATMENT & TRACTION, HI-LO | Apr 8, 1977 | Substantially Equivalent |
| K770609 | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | Apr 8, 1977 | Substantially Equivalent |
| K770509 | TABLE, MASSAGE AND TREATMENT | Apr 5, 1977 | Substantially Equivalent |