Gauge, Pressure, Coronary, Cardiopulmonary Bypass
The Coronary and Cardiopulmonary Bypass Pressure Gauge is a cardiovascular device used to monitor fluid pressure within a cardiopulmonary bypass circuit during open-heart surgery, ensuring safe and controlled perfusion. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before marketing. The product code is DXS and the applicable regulation is 21 CFR 870.4310, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DXS
- Device Class
- FDA class 2
- Regulation Number
- 870.4310
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | Dec 02, 2011 | Substantially Equivalent | Medtronic, Inc. |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | Dec 27, 1994 | Substantially Equivalent | Vascular Technology Incorporated |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Oct 31, 1991 | Substantially Equivalent | Lifestream Int'L, Inc. |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | May 10, 1990 | Substantially Equivalent | Shiley, Inc. |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | Nov 06, 1987 | Substantially Equivalent | American Omni Medical, Inc. |
| K862836 | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE | Sep 12, 1986 | Substantially Equivalent | Shiley, Inc. |
| K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | Aug 09, 1985 | Substantially Equivalent | Dlp, Inc. |
| K842194 | PRESSURE MONITOR | Aug 27, 1984 | Substantially Equivalent | Norton Texas Medical Products |
| K831750 | PM-3 | Jul 26, 1983 | Substantially Equivalent | Delta Medical Industries |
| K822822 | GAMBRO PRESSURE MONITOR PRM 10 | Oct 18, 1982 | Substantially Equivalent | Gambro, Inc. |
| K820912 | PMS-2 PRESSURE MONITOR SEPARATOR | May 18, 1982 | Substantially Equivalent | Delta Medical Industries |
| K781890 | CHAMBER, MC-1 DISPOSABLE PRESSURE | Dec 04, 1978 | Substantially Equivalent | Delta Medical Industries |
| K771764 | CORONARY PRESSURE PERFUSION PUMP | Sep 30, 1977 | Substantially Equivalent | 3M Health Care, Sarns |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.