FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
K Number: K953963
·
Decision Nov 27, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
5
Applicant Total
26
Review Days
97
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Basic Information
- Device Name
- RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
- K Number
- K953963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rusch, Inc.
- Date Received
- August 22, 1995
- Decision Date
- November 27, 1995
- Product Code
- BTS
- 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 |
|---|---|---|---|
| BTS | Tube, Bronchial (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTS), ordered by most recent decision date.
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BRONCHOSCOPY TUBE W/ULTRA LOCUFF
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BRONCHO-CATH
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Other Clearances by Rusch, Inc.
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|---|---|---|---|
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| K993194 | RUSCH MANUAL RESUSCITATOR BAG | Mar 24, 2000 | Substantially Equivalent |
| K980870 | RUSCH SILICONE FOLEY CATHETER | Jun 9, 1998 | Substantially Equivalent |
| K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | Jan 27, 1998 | Substantially Equivalent |
| K963779 | RUSCH ENTERAL FEEDING TUBE | May 23, 1997 | Substantially Equivalent |
| K970021 | RUSCH SUPRAPUBIC TRAY | Feb 7, 1997 | Substantially Equivalent |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Dec 17, 1996 | Substantially Equivalent |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | Jun 28, 1996 | Substantially Equivalent |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | Jun 27, 1996 | Substantially Equivalent |