FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K Number: K980466
·
Decision Feb 24, 1998
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
12
Review Days
18
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Basic Information
- Device Name
- PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
- K Number
- K980466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sims Portex, Inc.
- Date Received
- February 6, 1998
- Decision Date
- February 24, 1998
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
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Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
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Other Clearances by Sims Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K002201 | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER | Feb 5, 2001 | Substantially Equivalent |
| K002506 | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT | Dec 14, 2000 | Substantially Equivalent |
| K001318 | CPAP SYSTEM, MODEL 102001 | Jul 20, 2000 | Substantially Equivalent |
| K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | Apr 28, 2000 | Substantially Equivalent |
| K994275 | SIMS PORTEX ANESTHESIA CATHETER | Feb 22, 2000 | Substantially Equivalent |
| K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | Jan 18, 2000 | Substantially Equivalent |
| K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | Oct 22, 1999 | Substantially Equivalent |
| K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 | Sep 13, 1999 | Substantially Equivalent |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Jan 29, 1999 | Substantially Equivalent |