FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHETER, THORACIC DRAIN
K Number: K760136
·
Decision Jul 20, 1976
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
62
Review Days
22
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CATHETER, THORACIC DRAIN
- K Number
- K760136
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- June 28, 1976
- Decision Date
- July 20, 1976
- Product Code
- DWS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWS), ordered by most recent decision date.
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
FDA 510(k)
FDA Class 1
·Cardiovascular
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
FDA 510(k)
FDA Class 1
·Cardiovascular
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
FDA 510(k)
FDA Class 1
·Cardiovascular
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
FDA 510(k)
FDA Class 1
·Cardiovascular
G.E. STERILE ANGIOGRAPHIC TRAY
FDA 510(k)
FDA Class 1
·Cardiovascular
G.E. STERILE CT BIOPSY TRAY
FDA 510(k)
FDA Class 1
·Cardiovascular
Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |