FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
K Number: K862550
·
Decision Sep 2, 1986
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
24
Review Days
61
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Basic Information
- Device Name
- OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
- K Number
- K862550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Meadox Surgimed, Inc.
- Date Received
- July 3, 1986
- Decision Date
- September 2, 1986
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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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 |