FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MON-A-THERM FOLEY KIT
K Number: K923538
·
Decision May 27, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
43
Review Days
315
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Basic Information
- Device Name
- MON-A-THERM FOLEY KIT
- K Number
- K923538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Medical
- Date Received
- July 16, 1992
- Decision Date
- May 27, 1993
- Product Code
- FCM
- 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Mallinckrodt Medical
| K Number | Device Name | ||
|---|---|---|---|
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | Oct 2, 2008 | Substantially Equivalent |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | Jun 16, 2005 | Substantially Equivalent |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Dec 29, 1997 | Substantially Equivalent |
| K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | Sep 25, 1997 | Substantially Equivalent |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | Jun 26, 1997 | Substantially Equivalent |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mar 28, 1997 | Substantially Equivalent |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | Mar 20, 1997 | Substantially Equivalent |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | Nov 26, 1996 | Substantially Equivalent |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | Oct 4, 1996 | Substantially Equivalent |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | Mar 13, 1996 | Substantially Equivalent |