FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPACT BALLOON DILATION CATHETER
K Number: K983373
·
Decision Jun 22, 1999
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
2
Review Days
271
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Basic Information
- Device Name
- IMPACT BALLOON DILATION CATHETER
- K Number
- K983373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- B. Braun/Mcgaw
- Date Received
- September 24, 1998
- Decision Date
- June 22, 1999
- 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 |
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Other Clearances by B. Braun/Mcgaw
| K Number | Device Name | ||
|---|---|---|---|
| K994111 | CELSITE, MODELS ST401L, ST405L | Jan 3, 2000 | Substantially Equivalent |