FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH PRESSURE INJECTION LINES
K Number: K963749
·
Decision Dec 17, 1996
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
26
Review Days
90
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Basic Information
- Device Name
- HIGH PRESSURE INJECTION LINES
- K Number
- K963749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxxim Medical
- Date Received
- September 18, 1996
- Decision Date
- December 17, 1996
- 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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| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Dec 21, 1999 | Substantially Equivalent |
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| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | Jul 15, 1999 | Substantially Equivalent |