FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
K Number: K973840
·
Decision May 21, 1998
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
63
Review Days
225
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Basic Information
- Device Name
- FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
- K Number
- K973840
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daig Corp.
- Date Received
- October 8, 1997
- Decision Date
- May 21, 1998
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Daig Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 | Nov 29, 2000 | Substantially Equivalent |
| K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | May 15, 2000 | Substantially Equivalent |
| K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | Oct 19, 1998 | Substantially Equivalent |
| K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER | Sep 16, 1998 | Substantially Equivalent |
| 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 |
| K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | Dec 27, 1994 | Substantially Equivalent |