FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRE BALLOON DILATATION CATHETER
K Number: K971320
·
Decision Oct 9, 1997
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
432
Review Days
182
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Basic Information
- Device Name
- CRE BALLOON DILATATION CATHETER
- K Number
- K971320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- April 10, 1997
- Decision Date
- October 9, 1997
- Product Code
- KNQ
- 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNQ), ordered by most recent decision date.
CRE FIXED WIRE BALLON DILATION CATHETER
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FDA 510(k)
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COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
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FDA Class 2
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MAXFORCE TTS SINGLE-USE BALLOON DILATOR
FDA 510(k)
FDA Class 2
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| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Oct 21, 2014 | Substantially Equivalent |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Oct 17, 2014 | Substantially Equivalent |
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM | Oct 17, 2014 | Substantially Equivalent |