FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPYGLASS ANGIOGRAPHIC CATHETER
K Number: K962805
·
Decision Oct 15, 1996
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
63
Review Days
89
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Basic Information
- Device Name
- SPYGLASS ANGIOGRAPHIC CATHETER
- K Number
- K962805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Daig Corp.
- Date Received
- July 18, 1996
- Decision Date
- October 15, 1996
- 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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| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | May 14, 1997 | Substantially Equivalent |
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| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | Nov 28, 1995 | Substantially Equivalent |
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