FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESERET HEPARIN COATED FLOW CATH
K Number: K841251
·
Decision Jun 11, 1984
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
47
Review Days
77
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Basic Information
- Device Name
- DESERET HEPARIN COATED FLOW CATH
- K Number
- K841251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Parke-Davis Co.
- Date Received
- March 26, 1984
- Decision Date
- June 11, 1984
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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Other Clearances by Parke-Davis Co.
| K Number | Device Name | ||
|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | Dec 4, 1986 | Substantially Equivalent |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Aug 29, 1986 | Substantially Equivalent |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | Jun 18, 1986 | Substantially Equivalent |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | Mar 31, 1986 | Substantially Equivalent |
| K860290 | VIAPIC CENTRAL LINE CATHETER | Mar 18, 1986 | Substantially Equivalent |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | Nov 1, 1985 | Substantially Equivalent |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | Aug 19, 1985 | Substantially Equivalent |
| K851327 | DESERET ARTERIAL CATHETER | Jun 14, 1985 | Substantially Equivalent |
| K852078 | SPECTRUM(TENTATIVE) | Jun 7, 1985 | Substantially Equivalent |
| K844840 | DESERET INTRODUCER SET | May 16, 1985 | Substantially Equivalent |