FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPONSE(TM) STEERABLE CATHETER
K Number: K913940
·
Decision Jan 26, 1993
Classifications
1
FEI Numbers
41
Registration Numbers
42
Same Product Code
40
Applicant Total
63
Review Days
511
Basic Information
- Device Name
- RESPONSE(TM) STEERABLE CATHETER
- K Number
- K913940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DAIG CORP.
- Date Received
- September 3, 1991
- Decision Date
- January 26, 1993
- Product Code
- DRA
- 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | Oct 19, 1998 | Substantially Equivalent |
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| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | May 14, 1997 | Substantially Equivalent |
| K965249 | SPYGLASS ANGIOGRAPHIC CATHETER | Feb 21, 1997 | Substantially Equivalent |
| K962805 | SPYGLASS ANGIOGRAPHIC CATHETER | Oct 15, 1996 | Substantially Equivalent |
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | Nov 28, 1995 | Substantially Equivalent |
| K944284 | CONTROL | Mar 3, 1995 | Substantially Equivalent |