FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K Number: K801355
·
Decision Jul 8, 1980
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
315
Review Days
29
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Basic Information
- Device Name
- BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
- K Number
- K801355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cordis Corp.
- Date Received
- June 9, 1980
- Decision Date
- July 8, 1980
- Product Code
- KOC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Cordis Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | May 4, 2012 | Substantially Equivalent |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Jul 9, 2010 | Substantially Equivalent |
| K082143 | MICRO GUIDE CATHETER XP | Aug 25, 2008 | Substantially Equivalent |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | Feb 6, 2008 | Unknown |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Apr 27, 2006 | Unknown |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | Apr 1, 2005 | Substantially Equivalent |
| K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Nov 8, 2004 | Unknown |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Dec 22, 2003 | Unknown |