FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
RUSCH TRACHEAL BRONCHIAL Y STENT
K Number: K953593
·
Decision Oct 13, 1995
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
26
Review Days
74
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Basic Information
- Device Name
- RUSCH TRACHEAL BRONCHIAL Y STENT
- K Number
- K953593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Rusch, Inc.
- Date Received
- July 31, 1995
- Decision Date
- October 13, 1995
- Product Code
- NYT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NYT), ordered by most recent decision date.
RUSCH POLYFLEX STENT KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUSCH POLYFLEX STENT KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |