FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-MEDICUS CANNULA INTRODUCER
K Number: K903410
·
Decision Oct 31, 1990
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
15
Review Days
92
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Basic Information
- Device Name
- BIO-MEDICUS CANNULA INTRODUCER
- K Number
- K903410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bio Medicus, Inc.
- Date Received
- July 31, 1990
- Decision Date
- October 31, 1990
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Bio Medicus, Inc.
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|---|---|---|---|
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| K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C | Jun 28, 1990 | Substantially Equivalent |
| K894980 | BIO-CAL 370 HEATER/COOLER | Nov 2, 1989 | Substantially Equivalent |
| K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | Dec 21, 1988 | Substantially Equivalent |
| K883956 | BIO-MEDICUS TUBING CONNECTORS | Oct 28, 1988 | Substantially Equivalent |
| K872033 | BIO-MEDICUS CANNULA-TUBING | Dec 7, 1987 | Substantially Equivalent |
| 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 |