FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
K Number: K981191
·
Decision Apr 7, 1999
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
15
Review Days
370
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Basic Information
- Device Name
- ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
- K Number
- K981191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intratherapeutics, Inc.
- Date Received
- April 2, 1998
- Decision Date
- April 7, 1999
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Intratherapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011184 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Aug 13, 2001 | Unknown |
| K003997 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Jan 24, 2001 | Unknown |
| K003040 | INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Dec 28, 2000 | Unknown |
| K003450 | INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS | Dec 7, 2000 | Unknown |
| K001648 | INTRASTENT DOUBLESTRUT PARAMOUNT | Aug 28, 2000 | Substantially Equivalent |
| K001257 | INTRACOIL STENT | May 18, 2000 | Substantially Equivalent |
| K000864 | INTRASTENT DOUBLESTRUT XS STENT | Apr 14, 2000 | Substantially Equivalent |
| K993904 | INTRASTENT DOUBLESTRUT LD | Feb 1, 2000 | Unknown |
| K992816 | MODIFICATION TO INTRASTENT | Oct 15, 1999 | Unknown |
| K992622 | INTRAMAX ITI GUIDE CATHETER | Sep 29, 1999 | Substantially Equivalent |