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FDA 510(k)

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)

K-Number: K202251 · 2020-08-31

ApplicantPenumbra, Inc.
Decision Date2020-08-31
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2020-08-31 under approval number K202251. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)?

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) is a medical device that received FDA 510(k) clearance on 2020-08-31. It is manufactured by Penumbra, Inc.. The 510(k) number is K202251.

When was Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) approved by the FDA?

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) received FDA 510(k) clearance on 2020-08-31, under approval number K202251.

What company makes Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)?

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)?

The FDA product code for Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) is NRY.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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