FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADULT VENT CATHETER
K Number: K834352
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
40
Applicant Total
56
Review Days
45
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
- ADULT VENT CATHETER
- K Number
- K834352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dlp, Inc.
- Date Received
- December 13, 1983
- Decision Date
- January 27, 1984
- Product Code
- DRA
- 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 |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRA), ordered by most recent decision date.
Globe Introducer (601-01001)
FDA 510(k)
FDA Class 2
·Cardiovascular
FARADRIVE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
FlexCath Contour Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
MitraClip G4 Steerable Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AcQGuide® VUE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Dlp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973485 | CLEARVIEW BLOWER/MISTER | Dec 8, 1997 | Substantially Equivalent |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Jan 30, 1997 | Substantially Equivalent |
| K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | Mar 26, 1996 | Substantially Equivalent |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Apr 25, 1995 | Substantially Equivalent |
| K934215 | CONTAIN-OR | Feb 9, 1994 | Substantially Equivalent |
| K915268 | CATHETER TWO STAGE VENOUS RETURN | Jul 27, 1992 | Substantially Equivalent |
| K913077 | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | Jan 9, 1992 | Substantially Equivalent |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Jan 9, 1992 | Substantially Equivalent |
| K913098 | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 | Nov 5, 1991 | Substantially Equivalent |
| K912229 | IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 | Sep 25, 1991 | Substantially Equivalent |