FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSULATION PAD
K Number: K896307
·
Decision Jan 19, 1990
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
26
Review Days
80
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
- INSULATION PAD
- K Number
- K896307
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bio-Vascular, Inc.
- Date Received
- October 31, 1989
- Decision Date
- January 19, 1990
- 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 Bio-Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002233 | BVI SLING | Oct 13, 2000 | Substantially Equivalent |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | Feb 22, 2000 | Substantially Equivalent |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Nov 12, 1998 | Substantially Equivalent |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Nov 6, 1998 | Substantially Equivalent |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | Oct 9, 1998 | Substantially Equivalent |
| K981624 | FLO-THRU | Aug 4, 1998 | Substantially Equivalent |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Jul 30, 1998 | Substantially Equivalent |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Apr 10, 1998 | Substantially Equivalent |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Dec 24, 1997 | Substantially Equivalent |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Dec 16, 1997 | Substantially Equivalent |