CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
FDA 510(k) clearance K023907 · decided 2002-12-18
Clearance details
- K-number
- K023907
- Device name
- CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-25
- Decision date
- 2002-12-18
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- KNQ
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warren, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRE FIXED WIRE BALLON DILATION CATHETER (K122924) | Boston Scientific Corp | 2012-10-24 |
| ETHICON ENDO-SURGERYOPTICAL DILATOR (K093236) | Ethicon Endo-Surgery, Inc. | 2009-11-10 |
| HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183) | Cook Endoscopy | 2009-09-25 |
| SMART DILATOR (K082995) | Safestitch Medical | 2009-02-06 |
| COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937) | Cook Endoscopy | 2006-12-01 |
| MAXFORCE TTS SINGLE-USE BALLOON DILATOR (K061787) | Boston Scientific Corp | 2006-09-21 |
| INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (K060302) | Cordis Europa, N.V. | 2006-04-11 |
| INSCOPE 3-STAGE BALLOON DILATOR (K043605) | Cordis Europa, N.V. | 2005-02-04 |
| BARD ELIMINATOR PET BALLOON DILATORS (K033936) | C.R. Bard, Inc. | 2004-01-14 |
| OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (K031147) | Ethicon Endo-Surgery, Inc. | 2004-01-12 |
| MEDOVATIONS ESOPHAGEAL DILATOR (K002363) | Medovations, Inc. | 2000-11-01 |
| CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER (K993720) | Cordis Corp. | 2000-01-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |