FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEX BUBBLE TUBING
K Number: K832865
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
23
Applicant Total
39
Review Days
37
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Basic Information
- Device Name
- FLEX BUBBLE TUBING
- K Number
- K832865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sheridan Catheter Corp.
- Date Received
- August 23, 1983
- Decision Date
- September 29, 1983
- Product Code
- BYY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYY), ordered by most recent decision date.
VITAFLOW SUCTION/ASPIRATION TUBING SET
FDA 510(k)
FDA Class 2
·General Hospital
CONNECTING TUBING
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW
FDA 510(k)
FDA Class 2
·General Hospital
WILTEK IRRIGAITON/ASPIRATION TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922894 | LAZER-TRACH TRACHEAL TUBE | May 7, 1993 | Substantially Equivalent |
| 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 |