FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FlexCath Select Steerable Shealth and Dilator
K Number: K163268
·
Decision Feb 2, 2017
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
6
Review Days
73
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Basic Information
- Device Name
- FlexCath Select Steerable Shealth and Dilator
- K Number
- K163268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Cryocath, LP
- Date Received
- November 21, 2016
- Decision Date
- February 2, 2017
- 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 Medtronic Cryocath, LP
| K Number | Device Name | ||
|---|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Nov 13, 2020 | Substantially Equivalent |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Nov 26, 2018 | Substantially Equivalent |
| K142684 | FlexCath Select Steerable Sheath (10 French) | Nov 6, 2014 | Substantially Equivalent |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Dec 27, 2012 | Substantially Equivalent |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | Sep 1, 2010 | Substantially Equivalent |