Cre Fixed Wire Ballon Dilation Catheter
FDA 510(k) K122924 · Boston Scientific Corp
510(k) numberK122924
Submission
- Device name
- Cre Fixed Wire Ballon Dilation Catheter
- Applicant
- Boston Scientific Corp
Marlboro, MA, US - Received
- September 24, 2012
- Decision date
- October 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNQ – Dilator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093236 | Ethicon Endo-Surgeryoptical DilatorKNQ · Special | Ethicon Endo-Surgery, Inc. | 11/10/2009SE |
| K090183 | Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special | Cook Endoscopy | 09/25/2009SE |
| K082995 | Smart DilatorKNQ · Traditional | Safestitch Medical | 02/06/2009SE |
| K061937 | Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional | Cook Endoscopy | 12/01/2006SE |
| K061787 | Maxforce TTS Single-Use Balloon DilatorKNQ · Traditional | Boston Scientific Corp | 09/21/2006SE |
| K060302 | Inscope Precision Balloon Dilator - Wire GuidedKNQ · Traditional | Cordis Europa, N.V. | 04/11/2006SE |
| K043605 | Inscope 3-STAGE Balloon DilatorKNQ · Traditional | Cordis Europa, N.V. | 02/04/2005SE |
| K033936 | Bard Eliminator PET Balloon DilatorsKNQ · Special | C.R. Bard, Inc. | 01/14/2004SE |
| K031147 | Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional | Ethicon Endo-Surgery, Inc. | 01/12/2004SE |
| K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon…KNQ · Special | Cordis Corp. | 12/18/2002SE |
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Questions and answers
When was Cre Fixed Wire Ballon Dilation Catheter cleared by the FDA?
Cre Fixed Wire Ballon Dilation Catheter (K122924) received a 510(k) decision of Substantially Equivalent on October 24, 2012, 30 days after the submission was received.
What is the product code of K122924?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.