FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOUBLE-SWIVEL CONNECTOR
K Number: K850964
·
Decision May 14, 1985
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
39
Review Days
67
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Basic Information
- Device Name
- DOUBLE-SWIVEL CONNECTOR
- K Number
- K850964
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sheridan Catheter Corp.
- Date Received
- March 8, 1985
- Decision Date
- May 14, 1985
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |