FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LOW PROFILE CATHETER
K Number: K922567
·
Decision Nov 21, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
26
Review Days
1268
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Basic Information
- Device Name
- LOW PROFILE CATHETER
- K Number
- K922567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Rusch, Inc.
- Date Received
- June 1, 1992
- Decision Date
- November 21, 1995
- 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 Rusch, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010420 | RUSCH MMG/O'NEIL CATHETER | May 9, 2001 | Substantially Equivalent |
| K993528 | RUSCH EMERGENCY MASK | May 31, 2000 | Substantially Equivalent |
| K993194 | RUSCH MANUAL RESUSCITATOR BAG | Mar 24, 2000 | Substantially Equivalent |
| K980870 | RUSCH SILICONE FOLEY CATHETER | Jun 9, 1998 | Substantially Equivalent |
| K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | Jan 27, 1998 | Substantially Equivalent |
| K963779 | RUSCH ENTERAL FEEDING TUBE | May 23, 1997 | Substantially Equivalent |
| K970021 | RUSCH SUPRAPUBIC TRAY | Feb 7, 1997 | Substantially Equivalent |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Dec 17, 1996 | Substantially Equivalent |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | Jun 28, 1996 | Substantially Equivalent |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | Jun 27, 1996 | Substantially Equivalent |