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Innolitics
Anesthesiology
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
DWM
Apparatus, Suction, Patient Care
2
Product Code
K
21
2696
Aspira Pleural Drainage System
2
Cleared 510(K)
K
21
0509
Rocket Platinum Cured Cathter
2
Cleared 510(K)
K
20
1404
Passio Pump Drainage System
2
Cleared 510(K)
K
19
0292
Passio Pump Drainage System
2
Cleared 510(K)
K
16
3321
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
2
Cleared 510(K)
K
16
0450
Pleurx Pleural Catheter System
2
Cleared 510(K)
K
14
1965
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
2
Cleared 510(K)
K
12
3033
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
2
Cleared 510(K)
K
12
1849
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
2
Cleared 510(K)
K
11
2831
PLEURX PLEURAL CATHETER SYSTEMS
2
Cleared 510(K)
Show All 19 Submissions
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
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Review Panel
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Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-f—cardiovascular-therapeutic-devices
/
DWM
/
K212696
View Source
Aspira Pleural Drainage System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212696
510(k) Type
Traditional
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
555 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
DWM
Apparatus, Suction, Patient Care
K
21
2696
Aspira Pleural Drainage System
K
21
0509
Rocket Platinum Cured Cathter
K
20
1404
Passio Pump Drainage System
K
19
0292
Passio Pump Drainage System
K
16
3321
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
K
16
0450
Pleurx Pleural Catheter System
K
14
1965
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K
12
3033
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
K
12
1849
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
K
11
2831
PLEURX PLEURAL CATHETER SYSTEMS
Show All 19 Submissions
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—cardiovascular-therapeutic-devices
/
DWM
/
K212696
View Source
Aspira Pleural Drainage System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212696
510(k) Type
Traditional
Applicant
Merit Medical Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
555 days
Submission Type
Summary