FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
K Number: K961287
·
Decision Jul 26, 1996
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
19
Review Days
114
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Basic Information
- Device Name
- ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
- K Number
- K961287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rocket Medical Plc
- Date Received
- April 3, 1996
- Decision Date
- July 26, 1996
- Product Code
- KDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Mar 29, 2016 | Unknown |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Feb 1, 2013 | Substantially Equivalent |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Oct 17, 2005 | Substantially Equivalent |
| K042264 | GUIDEWIRES | Nov 24, 2004 | Substantially Equivalent |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Oct 4, 2004 | Substantially Equivalent |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Aug 8, 2003 | Substantially Equivalent |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Apr 19, 2000 | Substantially Equivalent |