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FDA 510(k)

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300

K-Number: K133587 · 2013-12-20

ApplicantSt. Jude Medical Systems AB
Decision Date2013-12-20
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical Systems AB. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133587. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300?

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is St. Jude Medical Systems AB. The 510(k) number is K133587.

When did PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 receive FDA 510(k) clearance?

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133587.

Who is the listed applicant for PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300?

The FDA 510(k) record lists St. Jude Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300?

The FDA product code for PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 is DRG.

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Other records listing St. Jude Medical Systems AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131452PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300K111854AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVERK110193FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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