FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEADOX SURGIMED GUIDE CATHETER
K Number: K860429
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
24
Review Days
78
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Basic Information
- Device Name
- MEADOX SURGIMED GUIDE CATHETER
- K Number
- K860429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Meadox Surgimed, Inc.
- Date Received
- February 4, 1986
- Decision Date
- April 23, 1986
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Meadox Surgimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944143 | MS CLASSIQUE BALLOON CATHETER | Mar 13, 1995 | Substantially Equivalent |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Mar 9, 1995 | Substantially Equivalent |
| K942382 | MS AMPLATZ EXTRA STIFF GUIDE WIRE | Aug 22, 1994 | Substantially Equivalent |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | Jun 9, 1993 | Substantially Equivalent |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | Jun 20, 1991 | Substantially Equivalent |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Mar 6, 1991 | Substantially Equivalent |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | Feb 25, 1991 | Substantially Equivalent |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Jan 30, 1991 | Substantially Equivalent |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | Jul 16, 1990 | Substantially Equivalent |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | Jun 20, 1989 | Substantially Equivalent |