FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
MOF
Guide, Wire, Catheter, Neurovasculature
2
Product Code
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
2
Product Code
NRY
Catheter, Thrombus Retriever
2
Product Code
K
24
3080
Riptide Aspiration System
2
Cleared 510(K)
K
24
1221
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
2
Cleared 510(K)
K
24
0917
Esperance 3+ Aspiration Catheter System
2
Cleared 510(K)
K
24
2504
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
2
Cleared 510(K)
K
23
4083
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
2
Cleared 510(K)
K
23
3329
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
2
Cleared 510(K)
K
23
2971
APRO 55 Catheter and Alembic Aspiration Tubing
2
Cleared 510(K)
K
23
3988
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
2
Cleared 510(K)
K
23
2524
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
2
Cleared 510(K)
K
22
3913
Socrates Aspiration System
2
Cleared 510(K)
K
22
2786
072 Aspiration System
2
Cleared 510(K)
K
23
0429
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
2
Cleared 510(K)
K
22
3530
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
2
Cleared 510(K)
K
23
0695
APRO 70 Catheter and Alembic Aspiration Tubing
2
Cleared 510(K)
K
22
1934
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
2
Cleared 510(K)
K
22
3545
APRO 70 Catheter and Alembic Aspiration Tubing
2
Cleared 510(K)
K
22
2808
Penumbra System (Reperfusion Catheter RED 43)
2
Cleared 510(K)
K
22
0808
Tigertriever 13 Revascularization Device
2
Cleared 510(K)
K
21
1120
ERIC Retrieval Device
2
Cleared 510(K)
K
21
1697
Esperance Aspiration Catheter System
2
Cleared 510(K)
K
21
2908
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
2
Cleared 510(K)
K
21
1654
Penumbra System (Reperfusion Catheter RED 72)
2
Cleared 510(K)
K
21
1338
EMBOTRAP III Revascularization Device
2
Cleared 510(K)
K
21
1411
Penumbra System (RED 68 Reperfusion Catheter)
2
Cleared 510(K)
K
21
1476
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
2
Cleared 510(K)
K
20
3440
Penumbra System (Reperfusion Catheter RED 62)
2
Cleared 510(K)
K
21
0996
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
2
Cleared 510(K)
K
20
3592
Tigertriever and Tigertriever 17 Revascularization Devce
2
Cleared 510(K)
K
20
2182
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
2
Cleared 510(K)
K
20
2251
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
2
Cleared 510(K)
K
20
1689
Riptide Aspiration System
2
Cleared 510(K)
K
19
3380
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
2
Cleared 510(K)
K
19
3063
EMBOTRAP III Revascularization Device
2
Cleared 510(K)
K
19
1946
Penumbra System Penumbra JET 7X
2
Cleared 510(K)
K
19
0338
046 Zenith Flex
2
Cleared 510(K)
K
19
1768
AXS Vecta Aspiration System
2
Cleared 510(K)
K
19
0010
Penumbra System Reperfusion Catheter JET 7
2
Cleared 510(K)
K
19
0464
Penumbra System 3D Revascularization Device
2
Cleared 510(K)
K
19
0212
AXS Vecta Aspiration System
2
Cleared 510(K)
K
18
3043
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
2
Cleared 510(K)
K
18
3464
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
2
Cleared 510(K)
K
18
3185
Riptide Aspiration System (Riptide Large Bore Aspiration System)
2
Cleared 510(K)
K
18
2101
Riptide Aspiration System (React 71 Catheter)
2
Cleared 510(K)
K
18
1354
074 Zenith Flex System
2
Cleared 510(K)
K
18
2522
Penumbra System (Modified 110 Aspiration Tubing)
2
Cleared 510(K)
K
17
3761
Penumbra System Reperfusion Catheter JET 7
2
Cleared 510(K)
K
18
0705
Riptide Aspiration System React 68 Catheter
2
Cleared 510(K)
K
18
0008
Penumbra System
2
Cleared 510(K)
K
17
3200
SOFIA Plus Aspiration Catheter
2
Cleared 510(K)
K
17
3452
EmboTrap ll Revascularization Device
2
Cleared 510(K)
K
17
2167
Zenith Flex System
2
Cleared 510(K)
K
17
3841
AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
2
Cleared 510(K)
K
17
2448
Riptide Aspiration System
2
Cleared 510(K)
K
16
2901
Penumbra 3D Revascularization Device
2
Cleared 510(K)
K
16
0641
Solitaire Platinum Revascularization Device, 6x40 mm
2
Cleared 510(K)
K
16
1879
Solitaire Platinum Revascularization Device
2
Cleared 510(K)
K
16
1640
Penumbra System ACE 68 Reperfusion Catheter
2
Cleared 510(K)
K
16
1064
Penumbra System ACE 68 Reperfusion Catheter
2
Cleared 510(K)
K
16
0449
Penumbra System, Penumbra Pump MAX
2
Cleared 510(K)
K
15
2541
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
2
Cleared 510(K)
K
15
3071
Solitaire Platinum Revascularization Device
2
Cleared 510(K)
K
15
1623
Penumbra System 110 Aspiration Tubing
2
Cleared 510(K)
K
15
0616
Trevo XP ProVue Retriever (4x30mm)
2
Cleared 510(K)
K
14
2458
Penumbra System ACE
2
Cleared 510(K)
K
14
3077
Trevo XP ProVue Retriever (6X25mm)
2
Cleared 510(K)
K
14
1516
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
2
Cleared 510(K)
K
14
1491
SOLITAIRE 2 REVASCULARIZATION DEVICE
2
Cleared 510(K)
K
13
3317
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
2
Cleared 510(K)
K
13
3464
MODIFIED TREVO PROVUE RETRIEVER
2
Cleared 510(K)
K
13
2641
MODIFIED TREVO PROVUE RETRIEVER
2
Cleared 510(K)
K
12
3378
SOLITAIRE 2 REVASCULARIZATION DEVICE
2
Cleared 510(K)
K
12
2478
MODIFIED TREVO RETRIEVER
2
Cleared 510(K)
K
12
0961
TREVO RETRIEVER
2
Cleared 510(K)
K
11
3455
SOLITAIRE FR REVASCULARIZATION DEVICE
2
Cleared 510(K)
K
11
3163
PENUMBRA SYSTEM MAX
2
Cleared 510(K)
K
09
3610
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
2
Cleared 510(K)
K
10
0769
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
2
Cleared 510(K)
K
09
0752
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
2
Cleared 510(K)
K
09
0085
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
2
Cleared 510(K)
K
08
2034
MODIFICATION TO MERCI RETRIEVER
2
Cleared 510(K)
K
08
1305
MERCI RETRIEVER
2
Cleared 510(K)
K
07
2718
PENUMBRA SYSTEM
2
Cleared 510(K)
K
07
1172
MODIFIED MERCI RETRIEVER, MODEL 90060
2
Cleared 510(K)
K
07
0521
MODIFIED MERCY RETRIEVER, MODEL 90070
2
Cleared 510(K)
K
06
3774
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
2
Cleared 510(K)
K
06
2046
MODIFIED MERCI RETRIEVER, MODEL 90050
2
Cleared 510(K)
K
06
1059
MODIFIED MERCI RETRIEVER, MODEL 90092
2
Cleared 510(K)
K
03
3736
MERCI RETRIEVER, MODELS 90065, 90066
2
Cleared 510(K)
NUI
Ultrasound, Infusion, System
2
Product Code
QBE
Cranial Sound Monitor
2
Product Code
QJP
Catheter, Percutaneous, Neurovasculature
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
NRY
/
K222808
View Source
Penumbra System (Reperfusion Catheter RED 43)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222808
510(k) Type
Traditional
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2022
Days to Decision
95 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
MOF
Guide, Wire, Catheter, Neurovasculature
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
NRY
Catheter, Thrombus Retriever
K
24
3080
Riptide Aspiration System
K
24
1221
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
K
24
0917
Esperance 3+ Aspiration Catheter System
K
24
2504
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
K
23
4083
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
K
23
3329
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K
23
2971
APRO 55 Catheter and Alembic Aspiration Tubing
K
23
3988
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
K
23
2524
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
K
22
3913
Socrates Aspiration System
K
22
2786
072 Aspiration System
K
23
0429
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
K
22
3530
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K
23
0695
APRO 70 Catheter and Alembic Aspiration Tubing
K
22
1934
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
K
22
3545
APRO 70 Catheter and Alembic Aspiration Tubing
K
22
2808
Penumbra System (Reperfusion Catheter RED 43)
K
22
0808
Tigertriever 13 Revascularization Device
K
21
1120
ERIC Retrieval Device
K
21
1697
Esperance Aspiration Catheter System
K
21
2908
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K
21
1654
Penumbra System (Reperfusion Catheter RED 72)
K
21
1338
EMBOTRAP III Revascularization Device
K
21
1411
Penumbra System (RED 68 Reperfusion Catheter)
K
21
1476
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
K
20
3440
Penumbra System (Reperfusion Catheter RED 62)
K
21
0996
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
K
20
3592
Tigertriever and Tigertriever 17 Revascularization Devce
K
20
2182
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
K
20
2251
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
K
20
1689
Riptide Aspiration System
K
19
3380
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
K
19
3063
EMBOTRAP III Revascularization Device
K
19
1946
Penumbra System Penumbra JET 7X
K
19
0338
046 Zenith Flex
K
19
1768
AXS Vecta Aspiration System
K
19
0010
Penumbra System Reperfusion Catheter JET 7
K
19
0464
Penumbra System 3D Revascularization Device
K
19
0212
AXS Vecta Aspiration System
K
18
3043
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
K
18
3464
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K
18
3185
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K
18
2101
Riptide Aspiration System (React 71 Catheter)
K
18
1354
074 Zenith Flex System
K
18
2522
Penumbra System (Modified 110 Aspiration Tubing)
K
17
3761
Penumbra System Reperfusion Catheter JET 7
K
18
0705
Riptide Aspiration System React 68 Catheter
K
18
0008
Penumbra System
K
17
3200
SOFIA Plus Aspiration Catheter
K
17
3452
EmboTrap ll Revascularization Device
K
17
2167
Zenith Flex System
K
17
3841
AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
K
17
2448
Riptide Aspiration System
K
16
2901
Penumbra 3D Revascularization Device
K
16
0641
Solitaire Platinum Revascularization Device, 6x40 mm
K
16
1879
Solitaire Platinum Revascularization Device
K
16
1640
Penumbra System ACE 68 Reperfusion Catheter
K
16
1064
Penumbra System ACE 68 Reperfusion Catheter
K
16
0449
Penumbra System, Penumbra Pump MAX
K
15
2541
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
K
15
3071
Solitaire Platinum Revascularization Device
K
15
1623
Penumbra System 110 Aspiration Tubing
K
15
0616
Trevo XP ProVue Retriever (4x30mm)
K
14
2458
Penumbra System ACE
K
14
3077
Trevo XP ProVue Retriever (6X25mm)
K
14
1516
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
K
14
1491
SOLITAIRE 2 REVASCULARIZATION DEVICE
K
13
3317
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K
13
3464
MODIFIED TREVO PROVUE RETRIEVER
K
13
2641
MODIFIED TREVO PROVUE RETRIEVER
K
12
3378
SOLITAIRE 2 REVASCULARIZATION DEVICE
K
12
2478
MODIFIED TREVO RETRIEVER
K
12
0961
TREVO RETRIEVER
K
11
3455
SOLITAIRE FR REVASCULARIZATION DEVICE
K
11
3163
PENUMBRA SYSTEM MAX
K
09
3610
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K
10
0769
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
K
09
0752
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
K
09
0085
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
K
08
2034
MODIFICATION TO MERCI RETRIEVER
K
08
1305
MERCI RETRIEVER
K
07
2718
PENUMBRA SYSTEM
K
07
1172
MODIFIED MERCI RETRIEVER, MODEL 90060
K
07
0521
MODIFIED MERCY RETRIEVER, MODEL 90070
K
06
3774
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
K
06
2046
MODIFIED MERCI RETRIEVER, MODEL 90050
K
06
1059
MODIFIED MERCI RETRIEVER, MODEL 90092
K
03
3736
MERCI RETRIEVER, MODELS 90065, 90066
NUI
Ultrasound, Infusion, System
QBE
Cranial Sound Monitor
QJP
Catheter, Percutaneous, Neurovasculature
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
NRY
/
K222808
View Source
Penumbra System (Reperfusion Catheter RED 43)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222808
510(k) Type
Traditional
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2022
Days to Decision
95 days
Submission Type
Summary