FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIFFER COAXIAL MICRO-INTRODUCER KIT
K Number: K071574
·
Decision Jul 5, 2007
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- STIFFER COAXIAL MICRO-INTRODUCER KIT
- K Number
- K071574
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Enpath Medical, Inc.
- Date Received
- June 8, 2007
- Decision Date
- July 5, 2007
- 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 Enpath Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081394 | PTFE INTERLOCK PEELABLE INTRODUCERS | Sep 15, 2008 | Substantially Equivalent |
| K072248 | VIAPEEL PEELABLE INTRODUCER | Nov 9, 2007 | Substantially Equivalent |
| K063182 | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX | Dec 21, 2006 | Substantially Equivalent |
| K061119 | ENPATH MEDICAL STEERABLE SHEATH | May 18, 2006 | Substantially Equivalent |