FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDENTI LOOPS DEGANIA SILICONE
K Number: K920104
·
Decision Apr 20, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
24
Review Days
102
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Basic Information
- Device Name
- IDENTI LOOPS DEGANIA SILICONE
- K Number
- K920104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Puritas Health Care, Inc.
- Date Received
- January 9, 1992
- Decision Date
- April 20, 1992
- Product Code
- DSS
- 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 |
|---|---|---|---|
| DSS | Clip, Vascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSS), ordered by most recent decision date.
MCAS (MODULAR CLIP APPLIER SYSTEM)
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HEARTPORT MULTIFIRE CLIP APPLIER
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RMI SOFCLAMP
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CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
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HORIZON SURGICAL LIGATING AND MARKING CLIP
FDA 510(k)
FDA Class 2
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SURGICAL SPRING CLIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Puritas Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942339 | SKIN NEUVEAU SCAR TREATMENT | Nov 28, 1994 | Substantially Equivalent |
| K941197 | SILK*SKIN SCAR TREATMENT | Aug 11, 1994 | Substantially Equivalent |
| K935600 | TRACHEAL SUCTION CATHETER | May 10, 1994 | Unknown |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | May 5, 1994 | Substantially Equivalent |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Apr 21, 1994 | Substantially Equivalent |
| K940055 | MULTISET | Apr 15, 1994 | Substantially Equivalent |
| K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET | Apr 15, 1994 | Substantially Equivalent |
| K935583 | SUCTION SET, TRACHAEL | Apr 11, 1994 | Unknown |
| K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM | Apr 4, 1994 | Substantially Equivalent |
| K935532 | TRANSFER SET | Apr 4, 1994 | Substantially Equivalent |