FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
K Number: K210626
·
Decision Apr 23, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
13
Review Days
52
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Basic Information
- Device Name
- SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
- K Number
- K210626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Corporation
- Date Received
- March 2, 2021
- Decision Date
- April 23, 2021
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Cordis Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | Apr 6, 2022 | Substantially Equivalent |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Feb 17, 2022 | Substantially Equivalent |
| K202167 | Brite Tip Radianz Guiding Sheath | Feb 26, 2021 | Substantially Equivalent |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | Oct 9, 2020 | Substantially Equivalent |
| K201333 | SABER .035 PTA Dilatation Catheter | Sep 11, 2020 | Substantially Equivalent |
| K181592 | RAIN Sheath Transradial | Aug 15, 2018 | Substantially Equivalent |
| K180081 | RAILWAY Sheathless Access System | Apr 18, 2018 | Substantially Equivalent |
| K143412 | ADROIT Guiding Catheter | Jan 14, 2015 | Substantially Equivalent |
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | Jun 27, 2014 | Substantially Equivalent |
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | Jun 14, 2012 | Substantially Equivalent |