FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K Number: K930456
·
Decision Nov 17, 1993
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
28
Review Days
294
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Basic Information
- Device Name
- INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
- K Number
- K930456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Interventional Therapeutics Corp.
- Date Received
- January 27, 1993
- Decision Date
- November 17, 1993
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Interventional Therapeutics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960832 | OCCLUSION BALLOON CATHETER | May 29, 1996 | Substantially Equivalent |
| K950398 | CATHETER, BALLOON TYPE | Oct 5, 1995 | Substantially Equivalent |
| K945588 | DISPOSABLE 1CC SYRINGE WITH LUER LOCK | Feb 10, 1995 | Substantially Equivalent |
| K944354 | CONTOUR EMBOLI | Dec 13, 1994 | Substantially Equivalent |
| K914866 | ITC CONTOUR EMBOLI, MODIFICATION | Nov 9, 1993 | Substantially Equivalent |
| K931025 | INTHERM STASIS VALVE SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K931278 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Jul 23, 1993 | Substantially Equivalent |
| K922609 | ITC CATHETERS W/ HYDROMER | Apr 30, 1993 | Substantially Equivalent |
| K925876 | ITC BUNJI PLATINUM EMBOLIZATION COIL | Apr 15, 1993 | Substantially Equivalent |
| K925523 | ITC BUNJI PLATINUM EMBOLIZATION COIL | Mar 23, 1993 | Substantially Equivalent |