FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
4 SURE TM NASAL OXYGEN CANNULA
K Number: K922397
·
Decision Mar 18, 1993
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
11
Review Days
301
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Basic Information
- Device Name
- 4 SURE TM NASAL OXYGEN CANNULA
- K Number
- K922397
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boston Pacific Medical, Inc.
- Date Received
- May 21, 1992
- Decision Date
- March 18, 1993
- Product Code
- CAT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
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NASAL CANNULA
FDA 510(k)
FDA Class 1
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SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
·Anesthesiology
CANNULA NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 467
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Boston Pacific Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | Mar 28, 1994 | Unknown |
| K922402 | 4 SURE TM ENTERAL FEEDING BAG | Mar 25, 1994 | Substantially Equivalent |
| K931048 | 4-SURE NELATON CATHETER | Feb 14, 1994 | Substantially Equivalent |
| K931047 | 4-SURE FEMALE CATHETER | Feb 14, 1994 | Substantially Equivalent |
| K921852 | 4 SURE TM RECTAL TUBE | Oct 8, 1993 | Substantially Equivalent |
| K921853 | 4 SURE TM FEEDING TUBES | Jul 13, 1993 | Substantially Equivalent |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Jul 7, 1993 | Unknown |
| K922398 | 4 SURE TM ENEMA BAG SET | Jun 17, 1993 | Unknown |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | Dec 30, 1992 | Substantially Equivalent |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Jun 10, 1992 | Substantially Equivalent |