FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEST CATHETERS/THORACIC CATHETERS
K Number: K851048
·
Decision Jun 5, 1985
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
31
Review Days
83
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Basic Information
- Device Name
- CHEST CATHETERS/THORACIC CATHETERS
- K Number
- K851048
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medovations, Inc.
- Date Received
- March 14, 1985
- Decision Date
- June 5, 1985
- Product Code
- GBS
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Medovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | Mar 10, 2015 | Substantially Equivalent |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Nov 1, 2000 | Substantially Equivalent |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Feb 2, 1998 | Substantially Equivalent |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Dec 5, 1994 | Substantially Equivalent |
| K913678 | TROCAR CATHETER | Dec 16, 1991 | Substantially Equivalent |
| K905478 | YANKAUER SUCTION DEVICE | Dec 19, 1990 | Substantially Equivalent |
| K874309 | URETHAL CATHETER | Dec 7, 1987 | Substantially Equivalent |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Oct 14, 1987 | Substantially Equivalent |
| K864962 | OBERTO MOUTH PROP | Feb 19, 1987 | Substantially Equivalent |
| K864964 | 5 - IN - 1 CONNECTOR | Jan 20, 1987 | Substantially Equivalent |