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FDA 510(k)

LOCKING STYLET 2

K-Number: K970690 · 1997-05-20

ApplicantCook Pacemaker Corp.
Decision Date1997-05-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOCKING STYLET 2 is the device name listed in this FDA 510(k) record. The listed applicant is Cook Pacemaker Corp.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K970690. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCKING STYLET 2?

LOCKING STYLET 2 is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K970690.

When did LOCKING STYLET 2 receive FDA 510(k) clearance?

LOCKING STYLET 2 received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970690.

Who is the listed applicant for LOCKING STYLET 2?

The FDA 510(k) record lists Cook Pacemaker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOCKING STYLET 2?

The FDA product code for LOCKING STYLET 2 is DQX.

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Other records listing Cook Pacemaker Corp. as applicant

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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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