FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-MEDICUS TUBING CONNECTORS
K Number: K883956
·
Decision Oct 28, 1988
Classifications
1
FEI Numbers
149
Registration Numbers
150
Same Product Code
137
Applicant Total
15
Review Days
39
Basic Information
- Device Name
- BIO-MEDICUS TUBING CONNECTORS
- K Number
- K883956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BIO MEDICUS, INC.
- Date Received
- September 19, 1988
- Decision Date
- October 28, 1988
- Product Code
- DTL
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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| K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | Dec 21, 1988 | Substantially Equivalent |
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| K861096 | CARDIOPULMONARY CANNULA TUBING | May 21, 1986 | Substantially Equivalent |
| K854133 | BIO MEDICUS BIO CONSOLE 540 | Jan 8, 1986 | Substantially Equivalent |
| K853126 | BIO PACK MODEL 200 | Oct 11, 1985 | Substantially Equivalent |