FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACH CARE SET WITH MICROBAN
K Number: K964369
·
Decision Feb 11, 1997
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
26
Review Days
102
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Basic Information
- Device Name
- TRACH CARE SET WITH MICROBAN
- K Number
- K964369
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ballard Medical Products
- Date Received
- November 1, 1996
- Decision Date
- February 11, 1997
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K013892 | LUTZ NEEDLE | Jul 11, 2002 | Substantially Equivalent |
| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | Mar 28, 2000 | Substantially Equivalent |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | Oct 20, 1999 | Substantially Equivalent |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | May 3, 1999 | Substantially Equivalent |
| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | Sep 11, 1998 | Substantially Equivalent |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |
| K923487 | BAL CATH | Jul 30, 1993 | Unknown |