FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
BAL CATH
K Number: K923487
·
Decision Jul 30, 1993
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
26
Review Days
380
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
- BAL CATH
- K Number
- K923487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Ballard Medical Products
- Date Received
- July 15, 1992
- Decision Date
- July 30, 1993
- Product Code
- KTR
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KTR | Tube, Aspirating, Bronchoscope, Rigid | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTR), ordered by most recent decision date.
RIGID SUCTION TIPS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ARGYLE DELEE SUCTION CATHETER W/MUCOUS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ARGYLE TAUSSIG CULTURE CATHETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Ballard Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Mar 31, 2003 | Substantially Equivalent |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Oct 11, 2002 | Substantially Equivalent |
| 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 |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |