FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
K Number: K864897
·
Decision Jan 12, 1987
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
- K Number
- K864897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dale Medical Products, Inc.
- Date Received
- December 15, 1986
- Decision Date
- January 12, 1987
- Product Code
- GAX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAX), ordered by most recent decision date.
UNIQUET
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TOURNIQUET
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STERILE ESMARCH BANDAGE
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DEGANIA SILICONE TOURNIQUET
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UNIVERSAL TOURNIQUET
FDA 510(k)
FDA Class 1
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KINDERWRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Dale Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | Oct 30, 2008 | Substantially Equivalent |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | Feb 10, 2000 | Substantially Equivalent |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Jan 28, 1997 | Substantially Equivalent |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | Jul 30, 1996 | Substantially Equivalent |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Apr 24, 1995 | Substantially Equivalent |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | Dec 9, 1991 | Substantially Equivalent |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Jan 14, 1991 | Substantially Equivalent |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | Aug 15, 1989 | Substantially Equivalent |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | Nov 5, 1987 | Substantially Equivalent |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Feb 21, 1986 | Substantially Equivalent |