FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAZER-TRACH TRACHEAL TUBE
K Number: K922894
·
Decision May 7, 1993
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
39
Review Days
325
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Basic Information
- Device Name
- LAZER-TRACH TRACHEAL TUBE
- K Number
- K922894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sheridan Catheter Corp.
- Date Received
- June 16, 1992
- Decision Date
- May 7, 1993
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K897046 | LASER RESISTANT TRACHEAL TUBE | Mar 23, 1990 | Substantially Equivalent |
| K890823 | ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER | May 5, 1989 | Substantially Equivalent |
| K884765 | CLINICAL ELECTRONIC THERMOMETERS | Feb 16, 1989 | Substantially Equivalent |
| K882918 | KIM NASO-INTESTINAL TUBE | Dec 5, 1988 | Substantially Equivalent |
| K882127 | CLINICAL ELECTRONIC THERMOMETERS | Aug 4, 1988 | Substantially Equivalent |
| K881368 | CLINICAL ELECTONIC THERMOMETERS | Jul 13, 1988 | Substantially Equivalent |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | Jun 16, 1988 | Substantially Equivalent |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | May 18, 1988 | Substantially Equivalent |
| K880960 | NDYAG LASER TRACHEAL TUBE | Apr 29, 1988 | Substantially Equivalent |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Jan 19, 1988 | Substantially Equivalent |